Conference Coverage

Personalized medicine is just about the biggest buzzword in health. But neurologist Ellen M. Mowry, MD, of Johns Hopkins University, Baltimore, steers patients with multiple sclerosis (MS) away from the concept when she first starts talking to them about initial therapy options and possible ways to forestall disability down the line.

“I try to be quite honest,” she told colleagues at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “I describe the escalation and early intensive-therapy paradigms very broadly, and I tell them that we don’t have a great way of individualizing their treatment decisions at this point.”

Observational and clinical trials offer extremely limited insight, she said in a keynote address, so there aren’t any simple answers about the best strategies. However, she highlighted new research projects that aim to provide more reliable answers.

As Dr. Mowry noted, patients tend to do well early on regardless of the choice of drug, so the question isn’t how to immediately control MS. “I personally find that most people can have control of relapses and the development of new lesions. I don’t find that there are too many individuals these days who don’t achieve control of their inflammatory activity,” she said. “I’m really interested in understanding whether the treatment choices a person with MS and myself make – at the time of their diagnosis – matters with respect to how they’re doing several years down the road. One major question is: Should I be using higher-efficacy therapy right out of the gate to better impact long-term disability?”

Research suggests that disability in MS is declining dramatically, she said, although it’s not quite clear if this is caused by evolving definitions of the disease or better medications. If the latter is the case, it’s useful to know that “there have been several publications suggesting that using stronger therapies right out of the gate may have an even greater impact on the long-term disability trajectory [than lower-efficacy treatments],” she said.

But some studies in this area are observational and come with various weaknesses, she said. Clinical trials offer data of their own, but “the conditions of clinical trials are also not real world or generalizable.” They often have healthier subjects than physicians actually see, and their requirements – such as requiring patients to have failed certain therapies – can muddy the messages of their outcomes. And, she added, people are more complicated in real life than in these trials, with many having a mix of both higher- and lower-risk features.

So how can physicians make the best decisions? Dr. Mowry recommends considering several factors, such patient comorbidities and reproductive status, the way drugs are administered, monitoring requirements, and cost. Safety is crucial too. She noted that newly diagnosed patients with MS are very concerned about safety – “they’re very much afraid of risks of stronger medications” – and many choose escalation therapy instead of immediately embracing higher-efficacy therapy for that reason.

At her clinic, she doesn’t push quick decisions. “I find that the treatment-decision discussion with individuals with MS takes several appointments, which we offer typically in quick succession. If we go with the escalation route, we are very strongly conscientious about escalating if there’s breakthrough disease. For me, that means after the medication should have kicked in, we may indeed escalate that therapy right away if there’s a new relapse or more than one new lesion.”

As for the future, Dr. Mowry highlighted two ongoing clinical trials that are expected to provide guidance about first-line therapy options. One is TREAT-MS, which will track intermediate-term risk of disability based on choices regarding first-line and later therapy. The pragmatic trial aims to enroll 900 subjects for up to 5 years. The other is DELIVER-MS, which aims to track how treatment choices affect brain volume.

“We really do need more definitive data to support the early treatment choices that people need to make,” she said.

Dr. Mowry disclosed grant/research support from Biogen, Teva, and Genentech, as welll as honoraria (editorial royalties) from UpToDate.

Personalized medicine is just about the biggest buzzword in health. But neurologist Ellen M. Mowry, MD, of Johns Hopkins University, Baltimore, steers patients with multiple sclerosis (MS) away from the concept when she first starts talking to them about initial therapy options and possible ways to forestall disability down the line.

“I try to be quite honest,” she told colleagues at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “I describe the escalation and early intensive-therapy paradigms very broadly, and I tell them that we don’t have a great way of individualizing their treatment decisions at this point.”

Observational and clinical trials offer extremely limited insight, she said in a keynote address, so there aren’t any simple answers about the best strategies. However, she highlighted new research projects that aim to provide more reliable answers.

As Dr. Mowry noted, patients tend to do well early on regardless of the choice of drug, so the question isn’t how to immediately control MS. “I personally find that most people can have control of relapses and the development of new lesions. I don’t find that there are too many individuals these days who don’t achieve control of their inflammatory activity,” she said. “I’m really interested in understanding whether the treatment choices a person with MS and myself make – at the time of their diagnosis – matters with respect to how they’re doing several years down the road. One major question is: Should I be using higher-efficacy therapy right out of the gate to better impact long-term disability?”

Research suggests that disability in MS is declining dramatically, she said, although it’s not quite clear if this is caused by evolving definitions of the disease or better medications. If the latter is the case, it’s useful to know that “there have been several publications suggesting that using stronger therapies right out of the gate may have an even greater impact on the long-term disability trajectory [than lower-efficacy treatments],” she said.

But some studies in this area are observational and come with various weaknesses, she said. Clinical trials offer data of their own, but “the conditions of clinical trials are also not real world or generalizable.” They often have healthier subjects than physicians actually see, and their requirements – such as requiring patients to have failed certain therapies – can muddy the messages of their outcomes. And, she added, people are more complicated in real life than in these trials, with many having a mix of both higher- and lower-risk features.

So how can physicians make the best decisions? Dr. Mowry recommends considering several factors, such patient comorbidities and reproductive status, the way drugs are administered, monitoring requirements, and cost. Safety is crucial too. She noted that newly diagnosed patients with MS are very concerned about safety – “they’re very much afraid of risks of stronger medications” – and many choose escalation therapy instead of immediately embracing higher-efficacy therapy for that reason.

At her clinic, she doesn’t push quick decisions. “I find that the treatment-decision discussion with individuals with MS takes several appointments, which we offer typically in quick succession. If we go with the escalation route, we are very strongly conscientious about escalating if there’s breakthrough disease. For me, that means after the medication should have kicked in, we may indeed escalate that therapy right away if there’s a new relapse or more than one new lesion.”

As for the future, Dr. Mowry highlighted two ongoing clinical trials that are expected to provide guidance about first-line therapy options. One is TREAT-MS, which will track intermediate-term risk of disability based on choices regarding first-line and later therapy. The pragmatic trial aims to enroll 900 subjects for up to 5 years. The other is DELIVER-MS, which aims to track how treatment choices affect brain volume.

“We really do need more definitive data to support the early treatment choices that people need to make,” she said.

Dr. Mowry disclosed grant/research support from Biogen, Teva, and Genentech, as welll as honoraria (editorial royalties) from UpToDate.

Personalized medicine is just about the biggest buzzword in health. But neurologist Ellen M. Mowry, MD, of Johns Hopkins University, Baltimore, steers patients with multiple sclerosis (MS) away from the concept when she first starts talking to them about initial therapy options and possible ways to forestall disability down the line.

“I try to be quite honest,” she told colleagues at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “I describe the escalation and early intensive-therapy paradigms very broadly, and I tell them that we don’t have a great way of individualizing their treatment decisions at this point.”

Observational and clinical trials offer extremely limited insight, she said in a keynote address, so there aren’t any simple answers about the best strategies. However, she highlighted new research projects that aim to provide more reliable answers.

As Dr. Mowry noted, patients tend to do well early on regardless of the choice of drug, so the question isn’t how to immediately control MS. “I personally find that most people can have control of relapses and the development of new lesions. I don’t find that there are too many individuals these days who don’t achieve control of their inflammatory activity,” she said. “I’m really interested in understanding whether the treatment choices a person with MS and myself make – at the time of their diagnosis – matters with respect to how they’re doing several years down the road. One major question is: Should I be using higher-efficacy therapy right out of the gate to better impact long-term disability?”

Research suggests that disability in MS is declining dramatically, she said, although it’s not quite clear if this is caused by evolving definitions of the disease or better medications. If the latter is the case, it’s useful to know that “there have been several publications suggesting that using stronger therapies right out of the gate may have an even greater impact on the long-term disability trajectory [than lower-efficacy treatments],” she said.

But some studies in this area are observational and come with various weaknesses, she said. Clinical trials offer data of their own, but “the conditions of clinical trials are also not real world or generalizable.” They often have healthier subjects than physicians actually see, and their requirements – such as requiring patients to have failed certain therapies – can muddy the messages of their outcomes. And, she added, people are more complicated in real life than in these trials, with many having a mix of both higher- and lower-risk features.

So how can physicians make the best decisions? Dr. Mowry recommends considering several factors, such patient comorbidities and reproductive status, the way drugs are administered, monitoring requirements, and cost. Safety is crucial too. She noted that newly diagnosed patients with MS are very concerned about safety – “they’re very much afraid of risks of stronger medications” – and many choose escalation therapy instead of immediately embracing higher-efficacy therapy for that reason.

At her clinic, she doesn’t push quick decisions. “I find that the treatment-decision discussion with individuals with MS takes several appointments, which we offer typically in quick succession. If we go with the escalation route, we are very strongly conscientious about escalating if there’s breakthrough disease. For me, that means after the medication should have kicked in, we may indeed escalate that therapy right away if there’s a new relapse or more than one new lesion.”

As for the future, Dr. Mowry highlighted two ongoing clinical trials that are expected to provide guidance about first-line therapy options. One is TREAT-MS, which will track intermediate-term risk of disability based on choices regarding first-line and later therapy. The pragmatic trial aims to enroll 900 subjects for up to 5 years. The other is DELIVER-MS, which aims to track how treatment choices affect brain volume.

“We really do need more definitive data to support the early treatment choices that people need to make,” she said.

Dr. Mowry disclosed grant/research support from Biogen, Teva, and Genentech, as welll as honoraria (editorial royalties) from UpToDate.

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

A version of this article first appeared on Medscape.com.

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

A version of this article first appeared on Medscape.com.

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

A version of this article first appeared on Medscape.com.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.

sgame/thinkstockphotos.com

Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.

“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”

According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.

“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.

To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.

For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.

Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.

Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.

“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”

Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”

For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”

According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.

Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.

“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”

The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.

Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.

sgame/thinkstockphotos.com

Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.

“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”

According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.

“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.

To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.

For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.

Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.

Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.

“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”

Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”

For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”

According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.

Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.

“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”

The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.

Using stool samples to test for Helicobacter pylori antibiotic resistance provides highly similar results to those of gastric biopsy samples, which suggests that stool testing may be a safer, more convenient, and more cost-effective option, according to investigators.

sgame/thinkstockphotos.com

Head-to-head testing for resistance-associated mutations using next-generation sequencing (NGS) showed 92% concordance between the two sample types, with 100% technical success among polymerase chain reaction (PCR)–positive stool samples, lead author Steven Moss, MD, of Brown University, Providence, R.I., and colleagues reported.

“H. pylori eradication rates have declined largely due to rising antimicrobial resistance worldwide,” Dr. Moss said at the annual meeting of the American College of Gastroenterology. “There is therefore a need for rapid, accurate, reliable antibiotic resistance testing.”

According to Dr. Moss, molecular resistance testing of gastric biopsies yields similar results to culture-based testing of gastric biopsies, but endoscopic sample collection remains inconvenient and relatively costly, so “it is not commonly performed in many GI practices.

“Whether reliable resistance testing by NGS is possible from stool samples remains unclear,” Dr. Moss said.

To explore this possibility, Dr. Moss and colleagues recruited 262 patients scheduled for upper endoscopy at four sites in the United States. From each patient, two gastric biopsies were taken, and within 2 weeks of the procedure, prior to starting anti–H. pylori therapy, one stool sample was collected.

For gastric biopsy samples, H. pylori positivity was confirmed by PCR, whereas positivity in stool samples was confirmed by both fecal antigen testing and PCR. After confirmation, NGS was conducted, with screening for resistance-associated mutations to six commonly used antibiotics: clarithromycin, levofloxacin, metronidazole, tetracycline, amoxicillin, and rifabutin.

Out of 262 patients, 73 tested positive for H. pylori via stool testing; however, 2 of these patients had inadequate gastric DNA for analysis, leaving 71 patients in the evaluable dataset. Within this group, samples from 50 patients (70.4%) had at least one resistance-association mutation.

Among all 71 individuals, 65 patients (91.5%) had fully concordant results between the two sample types. In four out of the six discordant cases, there was only one difference in antibiotic-associated mutations. Concordance ranged from 89% for metronidazole mutations to 100% for tetracycline, amoxicillin, and rifabutin mutations.

“It is now possible to rapidly obtain susceptibility data without endoscopy,” Dr. Moss concluded. “Using NGS to determine H. pylori antibiotic resistance using stool obviates the cost, inconvenience, and risks of endoscopy resistance profiling.”

Dr. Moss noted that the cost of the stool-based test, through study sponsor American Molecular Laboratories, is about $450, and that the company is “working with various insurance companies to try to get [the test] reimbursed.”

For cases of H. pylori infection without resistance testing results, Dr. Moss recommended first-line treatment with quadruple bismuth–based therapy; however, he noted that “most gastroenterologists, in all kinds of practice, are not measuring their eradication success rate ... so it’s really difficult to know if your best guess is really the appropriate treatment.”

According to Lukasz Kwapisz, MD, of Baylor College of Medicine, Houston, the concordance results are “encouraging,” and suggest that stool-based testing “could be much easier for the patient and the clinician” to find ways to eradicate H. pylori infection.

Dr. Kwapisz predicted that it will take additional successful studies, as well as real-world data, to convert clinicians to the new approach. He suggested that the transition may be gradual, like the adoption of fecal calprotectin testing.

“I don’t know if it’s one singular defining study that will tell you: ‘Okay, we all have to use this [stool-based resistance testing],’ ” he said. “It kind of happens over time – over a 2- or 3-year stretch, I would think, with positive results.”

The study was supported by American Molecular Labs. The investigators disclosed additional relationships with Takeda, Phathom, and Redhill. Dr. Kwapisz reported no conflicts of interest.

Patients with mild to moderate facial acne who underwent four treatments with a novel laser prototype known as Accure experienced an 82% reduction in acne lesions at 12 weeks and a 90% reduction at 12 months, a development that indicates the promise this has a treatment for acne in the future.

Currently, “there is no strong evidence that lasers are better than conventional treatments for acne,” Fernanda H. Sakamoto, MD, PhD, said during a virtual course on laser and aesthetic skin therapy. Some patients struggling with acne “search for so many different options and they end up spending a lot of money,” which, she said, includes an estimated $222 million for laser treatment alone in 2019.

Unlike other existing laser and light options for acne treatment, however, Accure is the first light-based platform to selectively target and injure sebaceous glands, the main source of sebum production and the key to a durable solution for acne. The laser, which uses a 1,726-nm wavelength, is being developed by researchers at the Wellman Center for Photomedicine, at Massachusetts General Hospital, Boston and was granted the European CE mark, which allows marketing of the product in Europe, in May of 2020.

In 2012, Dr. Sakamoto, a dermatologist at the center, and her Wellman colleagues were the first to describe the use of selective photothermolysis to target sebaceous glands. “We found that the peak absorption of lipids in sebaceous glands occurs between 1,700 and 1,720 nm,” she said. “Compared to water, the contrast is not high, so for us to develop a laser that is selective for acne, we needed to develop a strong cooling system and we had to create different methods to make it more selective.” She said that it took about 10 years to develop this laser.

The latest Accure prototype features a smart laser handpiece for real time thermal monitoring and precise delivery of laser emissions. “We have developed a mathematical model which permits us to predict safe and effective treatment patterns,” Dr. Sakamoto said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It has a unique cooling system that can control and protect the skin.”

The clinical trial for Food and Drug Administration clearance, which was delayed because of the COVID-19 pandemic, is still underway, she said, and the hope is that the laser will cleared by the FDA by next year. She and her Wellman colleagues have been working with four veteran dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2021, more than 50 patients were enrolled in four IRB-approved studies and an additional 30 are enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the pilot facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment. The average lesion reduction at week 12 was 82% and the mean Visual Analog Scale score immediately after treatment was 2.10 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device with no adverse events.

“This laser is absorbed in the near-infrared spectrum, so there is no melanin absorption,” Dr. Sakamoto explained. “It’s pretty much a color-blind laser, so we can treat darker skin types safely, with no side effects.” In other findings, researchers observed a 45% reduction in acne lesions after one treatment session, which “keeps improving over time,” she said. “At 12 weeks, we have clearance of over 80% of the lesions.”

At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histological studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other follicular structures.

Dr. Sakamoto disclosed that she has received portions of patent royalties from Massachusetts General Hospital. Accure was cofounded by R. Rox Anderson, MD, the director of the Wellman Center.

dbrunk@mdedge.com

Patients with mild to moderate facial acne who underwent four treatments with a novel laser prototype known as Accure experienced an 82% reduction in acne lesions at 12 weeks and a 90% reduction at 12 months, a development that indicates the promise this has a treatment for acne in the future.

Currently, “there is no strong evidence that lasers are better than conventional treatments for acne,” Fernanda H. Sakamoto, MD, PhD, said during a virtual course on laser and aesthetic skin therapy. Some patients struggling with acne “search for so many different options and they end up spending a lot of money,” which, she said, includes an estimated $222 million for laser treatment alone in 2019.

Unlike other existing laser and light options for acne treatment, however, Accure is the first light-based platform to selectively target and injure sebaceous glands, the main source of sebum production and the key to a durable solution for acne. The laser, which uses a 1,726-nm wavelength, is being developed by researchers at the Wellman Center for Photomedicine, at Massachusetts General Hospital, Boston and was granted the European CE mark, which allows marketing of the product in Europe, in May of 2020.

In 2012, Dr. Sakamoto, a dermatologist at the center, and her Wellman colleagues were the first to describe the use of selective photothermolysis to target sebaceous glands. “We found that the peak absorption of lipids in sebaceous glands occurs between 1,700 and 1,720 nm,” she said. “Compared to water, the contrast is not high, so for us to develop a laser that is selective for acne, we needed to develop a strong cooling system and we had to create different methods to make it more selective.” She said that it took about 10 years to develop this laser.

The latest Accure prototype features a smart laser handpiece for real time thermal monitoring and precise delivery of laser emissions. “We have developed a mathematical model which permits us to predict safe and effective treatment patterns,” Dr. Sakamoto said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It has a unique cooling system that can control and protect the skin.”

The clinical trial for Food and Drug Administration clearance, which was delayed because of the COVID-19 pandemic, is still underway, she said, and the hope is that the laser will cleared by the FDA by next year. She and her Wellman colleagues have been working with four veteran dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2021, more than 50 patients were enrolled in four IRB-approved studies and an additional 30 are enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the pilot facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment. The average lesion reduction at week 12 was 82% and the mean Visual Analog Scale score immediately after treatment was 2.10 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device with no adverse events.

“This laser is absorbed in the near-infrared spectrum, so there is no melanin absorption,” Dr. Sakamoto explained. “It’s pretty much a color-blind laser, so we can treat darker skin types safely, with no side effects.” In other findings, researchers observed a 45% reduction in acne lesions after one treatment session, which “keeps improving over time,” she said. “At 12 weeks, we have clearance of over 80% of the lesions.”

At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histological studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other follicular structures.

Dr. Sakamoto disclosed that she has received portions of patent royalties from Massachusetts General Hospital. Accure was cofounded by R. Rox Anderson, MD, the director of the Wellman Center.

dbrunk@mdedge.com

Patients with mild to moderate facial acne who underwent four treatments with a novel laser prototype known as Accure experienced an 82% reduction in acne lesions at 12 weeks and a 90% reduction at 12 months, a development that indicates the promise this has a treatment for acne in the future.

Currently, “there is no strong evidence that lasers are better than conventional treatments for acne,” Fernanda H. Sakamoto, MD, PhD, said during a virtual course on laser and aesthetic skin therapy. Some patients struggling with acne “search for so many different options and they end up spending a lot of money,” which, she said, includes an estimated $222 million for laser treatment alone in 2019.

Unlike other existing laser and light options for acne treatment, however, Accure is the first light-based platform to selectively target and injure sebaceous glands, the main source of sebum production and the key to a durable solution for acne. The laser, which uses a 1,726-nm wavelength, is being developed by researchers at the Wellman Center for Photomedicine, at Massachusetts General Hospital, Boston and was granted the European CE mark, which allows marketing of the product in Europe, in May of 2020.

In 2012, Dr. Sakamoto, a dermatologist at the center, and her Wellman colleagues were the first to describe the use of selective photothermolysis to target sebaceous glands. “We found that the peak absorption of lipids in sebaceous glands occurs between 1,700 and 1,720 nm,” she said. “Compared to water, the contrast is not high, so for us to develop a laser that is selective for acne, we needed to develop a strong cooling system and we had to create different methods to make it more selective.” She said that it took about 10 years to develop this laser.

The latest Accure prototype features a smart laser handpiece for real time thermal monitoring and precise delivery of laser emissions. “We have developed a mathematical model which permits us to predict safe and effective treatment patterns,” Dr. Sakamoto said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “It has a unique cooling system that can control and protect the skin.”

The clinical trial for Food and Drug Administration clearance, which was delayed because of the COVID-19 pandemic, is still underway, she said, and the hope is that the laser will cleared by the FDA by next year. She and her Wellman colleagues have been working with four veteran dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2021, more than 50 patients were enrolled in four IRB-approved studies and an additional 30 are enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the pilot facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment. The average lesion reduction at week 12 was 82% and the mean Visual Analog Scale score immediately after treatment was 2.10 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device with no adverse events.

“This laser is absorbed in the near-infrared spectrum, so there is no melanin absorption,” Dr. Sakamoto explained. “It’s pretty much a color-blind laser, so we can treat darker skin types safely, with no side effects.” In other findings, researchers observed a 45% reduction in acne lesions after one treatment session, which “keeps improving over time,” she said. “At 12 weeks, we have clearance of over 80% of the lesions.”

At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histological studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other follicular structures.

Dr. Sakamoto disclosed that she has received portions of patent royalties from Massachusetts General Hospital. Accure was cofounded by R. Rox Anderson, MD, the director of the Wellman Center.

dbrunk@mdedge.com

Marijuana use is now a legal activity in many parts of the United States, but those managing patients with psychiatric disorders are in the difficult position of determining whether this use is helpful, harmful, or irrelevant to the underlying illness on the basis of limited and largely incomplete data, according to an overview of this issue presented at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

HighGradeRoots/iStock/Getty Images

While there is clear evidence that cannabis use relative to the general population “is more prevalent among patients with psychiatric disorders,” it is less certain how often this use is risky, said Diana M. Martinez, MD, professor of psychiatry at Columbia University in New York.

Independent of euphoric effects, cannabis can be perceived by individuals with psychiatric diagnosis as self-medication for feelings of stress, social anxiety, and insomnia, among other symptoms. These are the same reasons why many individuals without psychiatric conditions use cannabis-containing products.

The perception that cannabis use is generally benign presumably explains the successful efforts at legalization, but there are risks for those with or without psychiatric illnesses, Dr. Martinez pointed out at the meeting, sponsored by Medscape Live. Not least, about 20% of regular users of cannabis develop cannabis use disorder (CUD), a condition defined in the DSM-5 as the continued use of cannabis despite adverse consequences, such as dependence.
 

Impact of severe CUD ‘incapacitating’

“Of those who meet criteria for CUD, 23% have severe CUD, which is an incapacitating form,” reported Dr. Martinez, citing work led by Deborah Hasin, PhD, professor of clinical epidemiology at Columbia University.

However, relative to otherwise healthy individuals, those with a psychiatric diagnosis might face greater benefits or greater risks from cannabis use, according to Dr. Martinez, who cited a 2017 report from the National Academies of Science, Engineering, and Medicine (NASEM).

This report evaluated the potential risks and benefits on the basis of published studies.

There is limited evidence that regular cannabis increases rather than modifies symptoms of mania and hypomania in patients with bipolar disorder, according to the report. The report also cited limited evidence that cannabis use increases severity of posttraumatic stress disorder (PTSD). There was limited evidence of adverse effects on symptoms of anxiety, although this appeared to depend on daily or nearly daily use.

The report found no data of acceptable quality to draw conclusions about the effect of cannabis use on symptoms of depression.

In patients with attention-deficit/hyperactivity disorder (ADHD), “a recent study showed that daily but not occasional use of cannabis increased impulsivity but not inattention, working memory, or verbal intelligence,” said Dr. Martinez, citing a study published this year.

Some evidence also suggests that patients with a psychiatric disorder might benefit from cannabis use, but, again, this evidence is limited. For one example, it includes a potential reduction in symptoms of obsessive-compulsive disorder, Dr. Martinez said.
 

More support for cannabis in medical disease

Relative to the quality of evidence supporting benefit from cannabis in psychiatric disease, the data appear to be stronger for patients with medical illnesses, such as cancer. For example, Dr. Martinez cited evidence that tetrahydrocannabinol (THC), a major active ingredient in cannabis, improves sleep in the context of a medical illnesses. There is also evidence for anxiolytic effects in patients with a medical illness, although that is weaker.

In patients with or without a psychiatric disorder, marijuana does pose a risk of substance abuse disorder, and it shares the risks of intoxicants, such as inattention leading to increased risk of accidents, including motor vehicle accidents. This pertains to those with or without a psychiatric or medical condition, Dr. Martinez said.

While intermittent light use of cannabis appears to pose no risk or a very low risk of long-term adverse effects on cognition, at least in patients without psychiatric disorders, Dr. Martinez indicated that the risk-benefit ratio for any individual is use dependent. The risk of CUD, for example, increases with the frequency of exposure and the potency of the cannabis. Dr. Martinez indicated that a conservative approach is prudent with the limited evidence available for patients with psychiatric disorders.
 

Empirical evidence for therapeutic role

In published studies, other researchers have expressed interest in a potential therapeutic role of cannabis for psychiatric disorders, but there appears to be a general consensus that the supportive data remain weak. One expert who has written on this topic, Jerome Sarris, PhD, professor of integrative mental health, NICM Health Research Institute, Western Sydney University, Westmead, Australia, said that empirical evidence does support a benefit in selected patients.

“Of course, high THC forms are strongly discouraged in people with schizophrenia or high risk of developing psychotic disorder, or in youths,” Dr. Sarris explained. “However, there is a potential role for use in people with sleep and pain issues, and many find it beneficial to also assist with affective disorder symptoms.”

In a systematic review he led that was published last year, the evidence to support cannabis for psychiatric disorders was characterized as “embryonic.” However, small studies and case reports appear to support benefit for such indications as ADHD if precautions are taken.

“I certainly would not discourage use of prescribed standardized medicinal cannabis therapeutics for all people with psychiatric disorders,” Dr. Sarris said. He suggested that attention should be made to the THC potency and terpene composition of the products that patients with psychiatric disorders are taking.

Marijuana use is now a legal activity in many parts of the United States, but those managing patients with psychiatric disorders are in the difficult position of determining whether this use is helpful, harmful, or irrelevant to the underlying illness on the basis of limited and largely incomplete data, according to an overview of this issue presented at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

HighGradeRoots/iStock/Getty Images

While there is clear evidence that cannabis use relative to the general population “is more prevalent among patients with psychiatric disorders,” it is less certain how often this use is risky, said Diana M. Martinez, MD, professor of psychiatry at Columbia University in New York.

Independent of euphoric effects, cannabis can be perceived by individuals with psychiatric diagnosis as self-medication for feelings of stress, social anxiety, and insomnia, among other symptoms. These are the same reasons why many individuals without psychiatric conditions use cannabis-containing products.

The perception that cannabis use is generally benign presumably explains the successful efforts at legalization, but there are risks for those with or without psychiatric illnesses, Dr. Martinez pointed out at the meeting, sponsored by Medscape Live. Not least, about 20% of regular users of cannabis develop cannabis use disorder (CUD), a condition defined in the DSM-5 as the continued use of cannabis despite adverse consequences, such as dependence.
 

Impact of severe CUD ‘incapacitating’

“Of those who meet criteria for CUD, 23% have severe CUD, which is an incapacitating form,” reported Dr. Martinez, citing work led by Deborah Hasin, PhD, professor of clinical epidemiology at Columbia University.

However, relative to otherwise healthy individuals, those with a psychiatric diagnosis might face greater benefits or greater risks from cannabis use, according to Dr. Martinez, who cited a 2017 report from the National Academies of Science, Engineering, and Medicine (NASEM).

This report evaluated the potential risks and benefits on the basis of published studies.

There is limited evidence that regular cannabis increases rather than modifies symptoms of mania and hypomania in patients with bipolar disorder, according to the report. The report also cited limited evidence that cannabis use increases severity of posttraumatic stress disorder (PTSD). There was limited evidence of adverse effects on symptoms of anxiety, although this appeared to depend on daily or nearly daily use.

The report found no data of acceptable quality to draw conclusions about the effect of cannabis use on symptoms of depression.

In patients with attention-deficit/hyperactivity disorder (ADHD), “a recent study showed that daily but not occasional use of cannabis increased impulsivity but not inattention, working memory, or verbal intelligence,” said Dr. Martinez, citing a study published this year.

Some evidence also suggests that patients with a psychiatric disorder might benefit from cannabis use, but, again, this evidence is limited. For one example, it includes a potential reduction in symptoms of obsessive-compulsive disorder, Dr. Martinez said.
 

More support for cannabis in medical disease

Relative to the quality of evidence supporting benefit from cannabis in psychiatric disease, the data appear to be stronger for patients with medical illnesses, such as cancer. For example, Dr. Martinez cited evidence that tetrahydrocannabinol (THC), a major active ingredient in cannabis, improves sleep in the context of a medical illnesses. There is also evidence for anxiolytic effects in patients with a medical illness, although that is weaker.

In patients with or without a psychiatric disorder, marijuana does pose a risk of substance abuse disorder, and it shares the risks of intoxicants, such as inattention leading to increased risk of accidents, including motor vehicle accidents. This pertains to those with or without a psychiatric or medical condition, Dr. Martinez said.

While intermittent light use of cannabis appears to pose no risk or a very low risk of long-term adverse effects on cognition, at least in patients without psychiatric disorders, Dr. Martinez indicated that the risk-benefit ratio for any individual is use dependent. The risk of CUD, for example, increases with the frequency of exposure and the potency of the cannabis. Dr. Martinez indicated that a conservative approach is prudent with the limited evidence available for patients with psychiatric disorders.
 

Empirical evidence for therapeutic role

In published studies, other researchers have expressed interest in a potential therapeutic role of cannabis for psychiatric disorders, but there appears to be a general consensus that the supportive data remain weak. One expert who has written on this topic, Jerome Sarris, PhD, professor of integrative mental health, NICM Health Research Institute, Western Sydney University, Westmead, Australia, said that empirical evidence does support a benefit in selected patients.

“Of course, high THC forms are strongly discouraged in people with schizophrenia or high risk of developing psychotic disorder, or in youths,” Dr. Sarris explained. “However, there is a potential role for use in people with sleep and pain issues, and many find it beneficial to also assist with affective disorder symptoms.”

In a systematic review he led that was published last year, the evidence to support cannabis for psychiatric disorders was characterized as “embryonic.” However, small studies and case reports appear to support benefit for such indications as ADHD if precautions are taken.

“I certainly would not discourage use of prescribed standardized medicinal cannabis therapeutics for all people with psychiatric disorders,” Dr. Sarris said. He suggested that attention should be made to the THC potency and terpene composition of the products that patients with psychiatric disorders are taking.

Marijuana use is now a legal activity in many parts of the United States, but those managing patients with psychiatric disorders are in the difficult position of determining whether this use is helpful, harmful, or irrelevant to the underlying illness on the basis of limited and largely incomplete data, according to an overview of this issue presented at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

HighGradeRoots/iStock/Getty Images

While there is clear evidence that cannabis use relative to the general population “is more prevalent among patients with psychiatric disorders,” it is less certain how often this use is risky, said Diana M. Martinez, MD, professor of psychiatry at Columbia University in New York.

Independent of euphoric effects, cannabis can be perceived by individuals with psychiatric diagnosis as self-medication for feelings of stress, social anxiety, and insomnia, among other symptoms. These are the same reasons why many individuals without psychiatric conditions use cannabis-containing products.

The perception that cannabis use is generally benign presumably explains the successful efforts at legalization, but there are risks for those with or without psychiatric illnesses, Dr. Martinez pointed out at the meeting, sponsored by Medscape Live. Not least, about 20% of regular users of cannabis develop cannabis use disorder (CUD), a condition defined in the DSM-5 as the continued use of cannabis despite adverse consequences, such as dependence.
 

Impact of severe CUD ‘incapacitating’

“Of those who meet criteria for CUD, 23% have severe CUD, which is an incapacitating form,” reported Dr. Martinez, citing work led by Deborah Hasin, PhD, professor of clinical epidemiology at Columbia University.

However, relative to otherwise healthy individuals, those with a psychiatric diagnosis might face greater benefits or greater risks from cannabis use, according to Dr. Martinez, who cited a 2017 report from the National Academies of Science, Engineering, and Medicine (NASEM).

This report evaluated the potential risks and benefits on the basis of published studies.

There is limited evidence that regular cannabis increases rather than modifies symptoms of mania and hypomania in patients with bipolar disorder, according to the report. The report also cited limited evidence that cannabis use increases severity of posttraumatic stress disorder (PTSD). There was limited evidence of adverse effects on symptoms of anxiety, although this appeared to depend on daily or nearly daily use.

The report found no data of acceptable quality to draw conclusions about the effect of cannabis use on symptoms of depression.

In patients with attention-deficit/hyperactivity disorder (ADHD), “a recent study showed that daily but not occasional use of cannabis increased impulsivity but not inattention, working memory, or verbal intelligence,” said Dr. Martinez, citing a study published this year.

Some evidence also suggests that patients with a psychiatric disorder might benefit from cannabis use, but, again, this evidence is limited. For one example, it includes a potential reduction in symptoms of obsessive-compulsive disorder, Dr. Martinez said.
 

More support for cannabis in medical disease

Relative to the quality of evidence supporting benefit from cannabis in psychiatric disease, the data appear to be stronger for patients with medical illnesses, such as cancer. For example, Dr. Martinez cited evidence that tetrahydrocannabinol (THC), a major active ingredient in cannabis, improves sleep in the context of a medical illnesses. There is also evidence for anxiolytic effects in patients with a medical illness, although that is weaker.

In patients with or without a psychiatric disorder, marijuana does pose a risk of substance abuse disorder, and it shares the risks of intoxicants, such as inattention leading to increased risk of accidents, including motor vehicle accidents. This pertains to those with or without a psychiatric or medical condition, Dr. Martinez said.

While intermittent light use of cannabis appears to pose no risk or a very low risk of long-term adverse effects on cognition, at least in patients without psychiatric disorders, Dr. Martinez indicated that the risk-benefit ratio for any individual is use dependent. The risk of CUD, for example, increases with the frequency of exposure and the potency of the cannabis. Dr. Martinez indicated that a conservative approach is prudent with the limited evidence available for patients with psychiatric disorders.
 

Empirical evidence for therapeutic role

In published studies, other researchers have expressed interest in a potential therapeutic role of cannabis for psychiatric disorders, but there appears to be a general consensus that the supportive data remain weak. One expert who has written on this topic, Jerome Sarris, PhD, professor of integrative mental health, NICM Health Research Institute, Western Sydney University, Westmead, Australia, said that empirical evidence does support a benefit in selected patients.

“Of course, high THC forms are strongly discouraged in people with schizophrenia or high risk of developing psychotic disorder, or in youths,” Dr. Sarris explained. “However, there is a potential role for use in people with sleep and pain issues, and many find it beneficial to also assist with affective disorder symptoms.”

In a systematic review he led that was published last year, the evidence to support cannabis for psychiatric disorders was characterized as “embryonic.” However, small studies and case reports appear to support benefit for such indications as ADHD if precautions are taken.

“I certainly would not discourage use of prescribed standardized medicinal cannabis therapeutics for all people with psychiatric disorders,” Dr. Sarris said. He suggested that attention should be made to the THC potency and terpene composition of the products that patients with psychiatric disorders are taking.

An in-office age spot removal treatment known as Glacial Rx removes age spots without the risks, side effects, or limitations associated with heat-based devices, according to Arisa E. Ortiz, MD.

“What’s unique about this device is that I can see results without any downtime,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said during a virtual course on laser and aesthetic skin therapy. “Most other devices are not like that. It was well tolerated; there was minimal pain. There was no postinflammatory hyperpigmentation; it really is customizable to the patients’ needs.”

First cleared by the Food and Drug Administration in 2016 to remove benign lesions of the skin, Glacial Rx received an expanded indication in 2020 to temporarily reduce pain, swelling, and inflammation. The device, which was developed by R2 Technologies, relies on cryomodulation, a concept developed at Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, to improve skin appearance and freeze melanin at the source. “Cryomodulation pauses melanin production, but the melanocyte function is preserved, the epidermal barrier is not disrupted, and there is no persistent inflammatory response, which is key, because it decreases the risk of postinflammatory hyperpigmentation, especially in darker skin types,” Dr. Ortiz said.

Here’s how it works: The handpiece of the device is placed on top of the skin and cooling is delivered to targeted solar lentigos and other benign lesions. Ice nucleation takes place within the dendrites. As cell turnover takes place, melanin-free cells migrate upward and appear as new skin. “Clinically, this appears as clearance of the lesion,” Dr. Ortiz said.

She discussed her clinical experience treating 15 patients with a beta version of the device. Since that time, Glacial Rx was redesigned to include a smaller-tipped handpiece, easier and faster prep time, and a proprietary water-based gel to facilitate ice crystal propagation, which is applied to the targeted lesions just prior to treatment.

For the trial at UCSD, the researchers performed 29 treatment sessions on 15 patients with Fitzpatrick skin types I-IV, to gain clinical experience and evaluate the effectiveness of the device. They found that the treatment was well tolerated, with minimal discomfort. The amount of heat extracted ranged from 107 to 166 kJ/cm². No long-term dyschromia was observed, and some patients had lesion clearance after just one treatment.

“The settings are able to be titrated to where you have zero downtime, but you still get a lightening effect,” Dr. Ortiz said during the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “With other devices such as intense pulsed light, if you don’t see darkening than it probably didn’t work. With this device, you can titrate the length of the cooling and the temperature of the cooling.”

Posttreatment side effects commonly observed in the study were mild erythema, swelling, itching, and darkening. “There was minimal erythema in the higher settings, and some reports of itching and transient darkening in some of the higher settings,” she said.

Future indications for Glacial Rx may include psoriasis, acne, and rosacea. “We did try to use this for melasma,” she said. “It was effective, but I wouldn’t say it’s a cure for melasma. Melasma is very stubborn and requires a combination treatment, but it’s something we can use in our armamentarium.”

Dr. Ortiz reported having received consulting fees from R2 Technologies. She has been a paid consultant for and has received equipment from many device companies.

dbrunk@mdedge.com

An in-office age spot removal treatment known as Glacial Rx removes age spots without the risks, side effects, or limitations associated with heat-based devices, according to Arisa E. Ortiz, MD.

“What’s unique about this device is that I can see results without any downtime,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said during a virtual course on laser and aesthetic skin therapy. “Most other devices are not like that. It was well tolerated; there was minimal pain. There was no postinflammatory hyperpigmentation; it really is customizable to the patients’ needs.”

First cleared by the Food and Drug Administration in 2016 to remove benign lesions of the skin, Glacial Rx received an expanded indication in 2020 to temporarily reduce pain, swelling, and inflammation. The device, which was developed by R2 Technologies, relies on cryomodulation, a concept developed at Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, to improve skin appearance and freeze melanin at the source. “Cryomodulation pauses melanin production, but the melanocyte function is preserved, the epidermal barrier is not disrupted, and there is no persistent inflammatory response, which is key, because it decreases the risk of postinflammatory hyperpigmentation, especially in darker skin types,” Dr. Ortiz said.

Here’s how it works: The handpiece of the device is placed on top of the skin and cooling is delivered to targeted solar lentigos and other benign lesions. Ice nucleation takes place within the dendrites. As cell turnover takes place, melanin-free cells migrate upward and appear as new skin. “Clinically, this appears as clearance of the lesion,” Dr. Ortiz said.

She discussed her clinical experience treating 15 patients with a beta version of the device. Since that time, Glacial Rx was redesigned to include a smaller-tipped handpiece, easier and faster prep time, and a proprietary water-based gel to facilitate ice crystal propagation, which is applied to the targeted lesions just prior to treatment.

For the trial at UCSD, the researchers performed 29 treatment sessions on 15 patients with Fitzpatrick skin types I-IV, to gain clinical experience and evaluate the effectiveness of the device. They found that the treatment was well tolerated, with minimal discomfort. The amount of heat extracted ranged from 107 to 166 kJ/cm². No long-term dyschromia was observed, and some patients had lesion clearance after just one treatment.

“The settings are able to be titrated to where you have zero downtime, but you still get a lightening effect,” Dr. Ortiz said during the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “With other devices such as intense pulsed light, if you don’t see darkening than it probably didn’t work. With this device, you can titrate the length of the cooling and the temperature of the cooling.”

Posttreatment side effects commonly observed in the study were mild erythema, swelling, itching, and darkening. “There was minimal erythema in the higher settings, and some reports of itching and transient darkening in some of the higher settings,” she said.

Future indications for Glacial Rx may include psoriasis, acne, and rosacea. “We did try to use this for melasma,” she said. “It was effective, but I wouldn’t say it’s a cure for melasma. Melasma is very stubborn and requires a combination treatment, but it’s something we can use in our armamentarium.”

Dr. Ortiz reported having received consulting fees from R2 Technologies. She has been a paid consultant for and has received equipment from many device companies.

dbrunk@mdedge.com

An in-office age spot removal treatment known as Glacial Rx removes age spots without the risks, side effects, or limitations associated with heat-based devices, according to Arisa E. Ortiz, MD.

“What’s unique about this device is that I can see results without any downtime,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said during a virtual course on laser and aesthetic skin therapy. “Most other devices are not like that. It was well tolerated; there was minimal pain. There was no postinflammatory hyperpigmentation; it really is customizable to the patients’ needs.”

First cleared by the Food and Drug Administration in 2016 to remove benign lesions of the skin, Glacial Rx received an expanded indication in 2020 to temporarily reduce pain, swelling, and inflammation. The device, which was developed by R2 Technologies, relies on cryomodulation, a concept developed at Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, to improve skin appearance and freeze melanin at the source. “Cryomodulation pauses melanin production, but the melanocyte function is preserved, the epidermal barrier is not disrupted, and there is no persistent inflammatory response, which is key, because it decreases the risk of postinflammatory hyperpigmentation, especially in darker skin types,” Dr. Ortiz said.

Here’s how it works: The handpiece of the device is placed on top of the skin and cooling is delivered to targeted solar lentigos and other benign lesions. Ice nucleation takes place within the dendrites. As cell turnover takes place, melanin-free cells migrate upward and appear as new skin. “Clinically, this appears as clearance of the lesion,” Dr. Ortiz said.

She discussed her clinical experience treating 15 patients with a beta version of the device. Since that time, Glacial Rx was redesigned to include a smaller-tipped handpiece, easier and faster prep time, and a proprietary water-based gel to facilitate ice crystal propagation, which is applied to the targeted lesions just prior to treatment.

For the trial at UCSD, the researchers performed 29 treatment sessions on 15 patients with Fitzpatrick skin types I-IV, to gain clinical experience and evaluate the effectiveness of the device. They found that the treatment was well tolerated, with minimal discomfort. The amount of heat extracted ranged from 107 to 166 kJ/cm². No long-term dyschromia was observed, and some patients had lesion clearance after just one treatment.

“The settings are able to be titrated to where you have zero downtime, but you still get a lightening effect,” Dr. Ortiz said during the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “With other devices such as intense pulsed light, if you don’t see darkening than it probably didn’t work. With this device, you can titrate the length of the cooling and the temperature of the cooling.”

Posttreatment side effects commonly observed in the study were mild erythema, swelling, itching, and darkening. “There was minimal erythema in the higher settings, and some reports of itching and transient darkening in some of the higher settings,” she said.

Future indications for Glacial Rx may include psoriasis, acne, and rosacea. “We did try to use this for melasma,” she said. “It was effective, but I wouldn’t say it’s a cure for melasma. Melasma is very stubborn and requires a combination treatment, but it’s something we can use in our armamentarium.”

Dr. Ortiz reported having received consulting fees from R2 Technologies. She has been a paid consultant for and has received equipment from many device companies.

dbrunk@mdedge.com

Pain is as individual as patients are, a multiple sclerosis (MS) specialist told colleagues, and one size does not fit all when it comes to treatment. Flexibility and multiple strategies are key, especially considering that pain can evolve over time because of changes in MS and related conditions.

“Pain syndromes are incredibly common. They can happen in monophasic, neurological attacks, or relapsing conditions,” neurologist Scott Newsome, DO, of Johns Hopkins University, Baltimore, said in a presentation about pain at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “The good news is there are a lot of things that we can do to help our patients, and the buck does not just stop with oral medications.”

Dr. Newsome, president of the CMSC’s foundation, noted that pain syndromes affect most people who have spinal cord attacks. Research has suggested that the severity of initial attacks is a predictor of the severity of pain syndromes to come.

“There’s a number of triggers that can worsen these pain syndromes – not sleeping well the night before, anxiety, or when someone overheats,” he said. “A lot of our patients during the summertime, when they go out, they want to enjoy themselves and hang out with their family. If the ambient temperature is to a degree where they have increased symptoms, it really impacts their quality of life.”

Dr. Newsome urged colleagues to consider the three types of pain – primary, such as those related to spasticity or tonic spasms; secondary, which can be caused by weakness, reaction to weakness, and spasticity; and tertiary, which is the emotional response to pain.

Tertiary and secondary pain are often overlooked. On the latter front, “early on in my career, I was a big offender,” he said. “I would just focus how a person had a direct injury to the nervous system and not realize that their hip isn’t hurting because of it. It’s a compensatory mechanism after the direct injury, affecting the muscle skeletal system adversely, and having this wear-and-tear phenomenon – setting them up for advanced arthritis, or even a vascular necrosis.”

In regard to MS, he said, it’s helpful to understand pain syndromes. One type is neuropathic: pain that’s worse at night, doesn’t respond well to standard painkillers, and needs multiple therapies. Another type is paroxysmal cord phenomena, which include tonic spasms, Lhermitte’s sign (“an uncomfortable, shocking, vibrating, electrical pain that goes right down their spine” when the neck is flexed), and a condition known as MS hug. “Our patients will come in and say: ‘Oh, it feels like someone’s given me a bear hug or is strangling me.’”

What works as therapy for primary pain syndromes? “I personally don’t like opioids for any pain syndrome, for a lot of reasons,” he said, but a combination of other drugs can be helpful at low doses to start. “I’m a big believer in combining treatments that have different mechanism of actions” instead of, say, combining gabapentin with pregabalin, nerve drugs which work in similar ways.

Dr. Newsome recalled seeing a patient recently who said: “Oh, I tried that drug, I tried this drug, they didn’t help, and I couldn’t tolerate them.” Turns out the patient was taking maximum doses. “No wonder you didn’t tolerate it,” Dr. Newsome said.

Nonpharmaceutical interventions can play an important role, he said. “Believe it or not, we’ve had a lot of people get benefit from acupuncture and massage therapy. And we’ve had some people actually undergo spinal cord stimulation and get stimulators placed. It’s rare, but that’s a consideration for individuals who are refractory to everything you do.”

Medical marijuana, Botox, ketamine, and intrathecal baclofen are other options, he said.

Finally, he said, slowly taper a patient off pain medications if they’re pain free for 3 months. “If someone is doing nonpharmacological interventions, and they’re having a good deal of pain relief, then that’s definitely an opportunity to cut back on the pain medications.”

Pain is as individual as patients are, a multiple sclerosis (MS) specialist told colleagues, and one size does not fit all when it comes to treatment. Flexibility and multiple strategies are key, especially considering that pain can evolve over time because of changes in MS and related conditions.

“Pain syndromes are incredibly common. They can happen in monophasic, neurological attacks, or relapsing conditions,” neurologist Scott Newsome, DO, of Johns Hopkins University, Baltimore, said in a presentation about pain at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “The good news is there are a lot of things that we can do to help our patients, and the buck does not just stop with oral medications.”

Dr. Newsome, president of the CMSC’s foundation, noted that pain syndromes affect most people who have spinal cord attacks. Research has suggested that the severity of initial attacks is a predictor of the severity of pain syndromes to come.

“There’s a number of triggers that can worsen these pain syndromes – not sleeping well the night before, anxiety, or when someone overheats,” he said. “A lot of our patients during the summertime, when they go out, they want to enjoy themselves and hang out with their family. If the ambient temperature is to a degree where they have increased symptoms, it really impacts their quality of life.”

Dr. Newsome urged colleagues to consider the three types of pain – primary, such as those related to spasticity or tonic spasms; secondary, which can be caused by weakness, reaction to weakness, and spasticity; and tertiary, which is the emotional response to pain.

Tertiary and secondary pain are often overlooked. On the latter front, “early on in my career, I was a big offender,” he said. “I would just focus how a person had a direct injury to the nervous system and not realize that their hip isn’t hurting because of it. It’s a compensatory mechanism after the direct injury, affecting the muscle skeletal system adversely, and having this wear-and-tear phenomenon – setting them up for advanced arthritis, or even a vascular necrosis.”

In regard to MS, he said, it’s helpful to understand pain syndromes. One type is neuropathic: pain that’s worse at night, doesn’t respond well to standard painkillers, and needs multiple therapies. Another type is paroxysmal cord phenomena, which include tonic spasms, Lhermitte’s sign (“an uncomfortable, shocking, vibrating, electrical pain that goes right down their spine” when the neck is flexed), and a condition known as MS hug. “Our patients will come in and say: ‘Oh, it feels like someone’s given me a bear hug or is strangling me.’”

What works as therapy for primary pain syndromes? “I personally don’t like opioids for any pain syndrome, for a lot of reasons,” he said, but a combination of other drugs can be helpful at low doses to start. “I’m a big believer in combining treatments that have different mechanism of actions” instead of, say, combining gabapentin with pregabalin, nerve drugs which work in similar ways.

Dr. Newsome recalled seeing a patient recently who said: “Oh, I tried that drug, I tried this drug, they didn’t help, and I couldn’t tolerate them.” Turns out the patient was taking maximum doses. “No wonder you didn’t tolerate it,” Dr. Newsome said.

Nonpharmaceutical interventions can play an important role, he said. “Believe it or not, we’ve had a lot of people get benefit from acupuncture and massage therapy. And we’ve had some people actually undergo spinal cord stimulation and get stimulators placed. It’s rare, but that’s a consideration for individuals who are refractory to everything you do.”

Medical marijuana, Botox, ketamine, and intrathecal baclofen are other options, he said.

Finally, he said, slowly taper a patient off pain medications if they’re pain free for 3 months. “If someone is doing nonpharmacological interventions, and they’re having a good deal of pain relief, then that’s definitely an opportunity to cut back on the pain medications.”

Pain is as individual as patients are, a multiple sclerosis (MS) specialist told colleagues, and one size does not fit all when it comes to treatment. Flexibility and multiple strategies are key, especially considering that pain can evolve over time because of changes in MS and related conditions.

“Pain syndromes are incredibly common. They can happen in monophasic, neurological attacks, or relapsing conditions,” neurologist Scott Newsome, DO, of Johns Hopkins University, Baltimore, said in a presentation about pain at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). “The good news is there are a lot of things that we can do to help our patients, and the buck does not just stop with oral medications.”

Dr. Newsome, president of the CMSC’s foundation, noted that pain syndromes affect most people who have spinal cord attacks. Research has suggested that the severity of initial attacks is a predictor of the severity of pain syndromes to come.

“There’s a number of triggers that can worsen these pain syndromes – not sleeping well the night before, anxiety, or when someone overheats,” he said. “A lot of our patients during the summertime, when they go out, they want to enjoy themselves and hang out with their family. If the ambient temperature is to a degree where they have increased symptoms, it really impacts their quality of life.”

Dr. Newsome urged colleagues to consider the three types of pain – primary, such as those related to spasticity or tonic spasms; secondary, which can be caused by weakness, reaction to weakness, and spasticity; and tertiary, which is the emotional response to pain.

Tertiary and secondary pain are often overlooked. On the latter front, “early on in my career, I was a big offender,” he said. “I would just focus how a person had a direct injury to the nervous system and not realize that their hip isn’t hurting because of it. It’s a compensatory mechanism after the direct injury, affecting the muscle skeletal system adversely, and having this wear-and-tear phenomenon – setting them up for advanced arthritis, or even a vascular necrosis.”

In regard to MS, he said, it’s helpful to understand pain syndromes. One type is neuropathic: pain that’s worse at night, doesn’t respond well to standard painkillers, and needs multiple therapies. Another type is paroxysmal cord phenomena, which include tonic spasms, Lhermitte’s sign (“an uncomfortable, shocking, vibrating, electrical pain that goes right down their spine” when the neck is flexed), and a condition known as MS hug. “Our patients will come in and say: ‘Oh, it feels like someone’s given me a bear hug or is strangling me.’”

What works as therapy for primary pain syndromes? “I personally don’t like opioids for any pain syndrome, for a lot of reasons,” he said, but a combination of other drugs can be helpful at low doses to start. “I’m a big believer in combining treatments that have different mechanism of actions” instead of, say, combining gabapentin with pregabalin, nerve drugs which work in similar ways.

Dr. Newsome recalled seeing a patient recently who said: “Oh, I tried that drug, I tried this drug, they didn’t help, and I couldn’t tolerate them.” Turns out the patient was taking maximum doses. “No wonder you didn’t tolerate it,” Dr. Newsome said.

Nonpharmaceutical interventions can play an important role, he said. “Believe it or not, we’ve had a lot of people get benefit from acupuncture and massage therapy. And we’ve had some people actually undergo spinal cord stimulation and get stimulators placed. It’s rare, but that’s a consideration for individuals who are refractory to everything you do.”

Medical marijuana, Botox, ketamine, and intrathecal baclofen are other options, he said.

Finally, he said, slowly taper a patient off pain medications if they’re pain free for 3 months. “If someone is doing nonpharmacological interventions, and they’re having a good deal of pain relief, then that’s definitely an opportunity to cut back on the pain medications.”

Omar A. Ibrahimi, MD, PhD, hears some dermatology colleagues say they don’t bother to offer laser hair removal in their practices because they figure that the procedure is under the purview of medical spas, but he sees it differently.

“I offer laser hair removal in my practice as a way to protect my patients from being picked off by medical spas,” Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, said during a virtual course on laser and aesthetic skin therapy. “These patients are going to want to get laser hair removal. If they’re not going to have the opportunity to get it at your practice, they’re going to seek it elsewhere. When they go elsewhere, they’re going to be picked off for other procedures as well.”

First developed in 1995 by R. Rox Anderson, MD, and colleagues at The Wellman Center for Photomedicine, laser hair removal has become the gold standard for permanent hair destruction, and ranks as the most common energy-based procedure performed in the world, Dr. Ibrahimi said. “Results are very long lasting and durable beyond 2 years after treatment,” he said. “These patients tend to be highly satisfied and have permanence with these treatments.”
 

Treatment goal, patient selection

While the target chromophore for the procedure is melanin, the goal is to destroy the stem cells located in the hair bulge and the hair bulb. “This is technically called the extended theory of selective photothermolysis, but it’s the same concept except that our target chromophore and our desired target for destruction are slightly spatially separated,” he said.

Proper patient selection is key, so a focused medical history and physical exam are essential prior to the procedure. If unwanted hair is located on the face, jawline, or chest of a female, consider and ask about potential endocrine-related dysfunctions such as polycystic ovary syndrome (PCOS). “Getting those addressed can often help the hypertrichosis as well,” he said. “Another condition is explosive hypertrichosis where hair growth starts very suddenly. It’s uncommon but it’s something to think about.”

Pregnancy is not an absolute contraindication for laser hair removal, Dr. Ibrahimi continued, but he elects not to perform the procedure on pregnant patients. He also asks patients about any history of photosensitivity, active infection at the intended treatment site, keloids, or hypertrophic scarring. Past methods of hair removal also matter. “What we’re targeting is the pigment in the hair shafts,” he said. “So, if your patient is waxing or plucking or epilating or removing the hair in some manner, they’re actually removing the target chromophore.”

Patients with darker Fitzpatrick skin types can be treated safely but tanned individuals face a risk of complications because of active melanocytes. “As we approach summer in New England, we slow down the amount of hair removal we do because it’s a riskier procedure,” he said. “I recommend that my patients not get any significant amount of sun exposure a month before or after treatment.”

The color and quality of hair also drive treatment success. Black and brown terminal hairs absorb the millisecond laser energy, but white, gray, red, and light blond hairs lack adequate melanin to make them suitable target chromophores.

Excessive and unwanted body hair ranges in severity and can usually be classified as either hypertrichosis or hirsutism.

The desired clinical endpoint is perifollicular edema and erythema. Treatment parameters that can be varied with Food and Drug Administration–cleared devices include wavelength, fluence, pulse duration, spot size, and skin cooling. The most popular devices are the Alexandrite 755 nm laser; the diode 800 nm laser; and the 1064 nm Nd:YAG laser, which is safe for all skin types. “Often you have to use higher relative fluences to treat patients with the 1064 nm Nd:YAG because on the absorption spectrum, the 1064-nm wavelength has a relatively lower absorption for melanin compared to the alexandrite. However, you can still get effective, long-term hair reduction with the Nd:YAG laser,” he said (Arch Dermatol. 2008 Oct;144[10]:1323-7).

More recently, Dr. Ibrahimi and colleagues found that a 1060-nm diode laser system with multiple handpieces for permanent hair reduction was safe for all skin types, in an open label prospective study.

Higher fluences have been correlated with greater rates of permanent hair removal, but they also are more likely to cause undesired side effects. Dr. Ibrahimi advises clinicians new to laser hair removal to conduct a few different test spots and look for the desired clinical endpoint of perifollicular erythema and edema. “The highest fluence that gives you that endpoint without any adverse reactions is going to the best fluence for treatment,” he said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Do a few test spots, bring them back a week later and see which ones were tolerated well without any side effects and which weren’t. That gives you a good starting point for your treatment.”

Cooling down the epidermal melanin not only keeps the procedure safe, it’s a salve for pain. “There are a variety of methods of passive and active cooling,” said Dr. Ibrahimi, a member of the American Society for Dermatologic Surgery board of directors. “You can use something as simple as cold gel, but the active methods are better because once the method of passive application of cold gel warms up, you lose that cooling effect. You can use forced chilled air. Many commercial devices come with a cold tip which cools down the epidermal melanin. Others use dynamic cooling, which emit cryogen spray from a separate part of the handpiece. It hits right where the laser pulse is going to go, is absorbed by the skin, and it cools down the epidermal melanin.”


 

Treatment complications

Complications that can occur from treatment include pigmentary changes such as hyperpigmentation and hypopigmentation. “In lighter skinned individuals, sometimes excess fluence can lead to an erythematous appearance,” he said. “In darker-skinned individuals, this often manifests as hyperpigmentation and can be very long-lasting.” Dr. Ibrahimi ranks improper technique as a complication, “because ideally you want to lay your pulses down with 10%-15% overlap during treatment,” he explained. “If you don’t overlap, you’re going to have zones that don’t get any of the laser photons. If you do, then your patient is not going to be happy with you.”

Paradoxical hypertrichosis occurs in 1%-5% of patients, typically in women from Mediterranean, Middle Eastern, or South Asian ethnic backgrounds. This tends to develop on the lateral or jawline part of the face. “Often it occurs in the setting where they come in and want these vellus hairs treated,” he said. “Somehow the laser, instead of destroying the hair shaft, triggers it and stimulates it and can’t differentiate a vellus hair from a terminal hair. This is important to discuss during your informed consent, especially when you’re treating on the lateral jawline or the sideburn area. If this happens, you can treat through it.”

Transgender patients and future directions

Dr. Ibrahimi pointed out that increasing numbers of transgender patients are visiting dermatologists seeking laser hair removal. About 16 million Americans are estimated to have a gender identity that differs from the one assigned to them at birth, yet they face several barriers to care, “ranging from ignorance on our end to maybe our own biases being transposed onto these patients,” he said. “We really need to do a better job for them. We really have an obligation to provide good care for all of our patients.”

Transgender women typically seek hair removal on the face and neck as well as in the genital area to remove hairs in preparation for vaginoplasty. Transgender men typically seek hair reduction on the forearm or on the thigh, because those are graft sites in preparation for phalloplasty. As a resource for transgender care, he recommends the UCSF Transgender Care website.

As for future directions in the field, Dr. Ibrahimi predicted that hair removal devices for home use will continue to improve and become more widespread. “This raises a host of considerations, from the risk of eye damage to the risk for paradoxical hypertrichosis, and what happens when pigmented lesions get treated with these low-powered machines compared to the ones we have in our office,” he said. “I also think we’re going to see office-based devices with larger spot sizes, smarter devices that are capable of taking over more of the functions we do. I’m most excited about the potential for treating nonpigmented white hair or poorly pigmented blond or reddish hair in the future.”

Dr. Ibrahimi disclosed that he has received research funding and speaker honoraria from Lutronic, Lumenis, Cutera, and Syneron-Candela. He also holds stock in AVAVA Inc.

dbrunk@mdedge.com

Omar A. Ibrahimi, MD, PhD, hears some dermatology colleagues say they don’t bother to offer laser hair removal in their practices because they figure that the procedure is under the purview of medical spas, but he sees it differently.

“I offer laser hair removal in my practice as a way to protect my patients from being picked off by medical spas,” Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, said during a virtual course on laser and aesthetic skin therapy. “These patients are going to want to get laser hair removal. If they’re not going to have the opportunity to get it at your practice, they’re going to seek it elsewhere. When they go elsewhere, they’re going to be picked off for other procedures as well.”

First developed in 1995 by R. Rox Anderson, MD, and colleagues at The Wellman Center for Photomedicine, laser hair removal has become the gold standard for permanent hair destruction, and ranks as the most common energy-based procedure performed in the world, Dr. Ibrahimi said. “Results are very long lasting and durable beyond 2 years after treatment,” he said. “These patients tend to be highly satisfied and have permanence with these treatments.”
 

Treatment goal, patient selection

While the target chromophore for the procedure is melanin, the goal is to destroy the stem cells located in the hair bulge and the hair bulb. “This is technically called the extended theory of selective photothermolysis, but it’s the same concept except that our target chromophore and our desired target for destruction are slightly spatially separated,” he said.

Proper patient selection is key, so a focused medical history and physical exam are essential prior to the procedure. If unwanted hair is located on the face, jawline, or chest of a female, consider and ask about potential endocrine-related dysfunctions such as polycystic ovary syndrome (PCOS). “Getting those addressed can often help the hypertrichosis as well,” he said. “Another condition is explosive hypertrichosis where hair growth starts very suddenly. It’s uncommon but it’s something to think about.”

Pregnancy is not an absolute contraindication for laser hair removal, Dr. Ibrahimi continued, but he elects not to perform the procedure on pregnant patients. He also asks patients about any history of photosensitivity, active infection at the intended treatment site, keloids, or hypertrophic scarring. Past methods of hair removal also matter. “What we’re targeting is the pigment in the hair shafts,” he said. “So, if your patient is waxing or plucking or epilating or removing the hair in some manner, they’re actually removing the target chromophore.”

Patients with darker Fitzpatrick skin types can be treated safely but tanned individuals face a risk of complications because of active melanocytes. “As we approach summer in New England, we slow down the amount of hair removal we do because it’s a riskier procedure,” he said. “I recommend that my patients not get any significant amount of sun exposure a month before or after treatment.”

The color and quality of hair also drive treatment success. Black and brown terminal hairs absorb the millisecond laser energy, but white, gray, red, and light blond hairs lack adequate melanin to make them suitable target chromophores.

Excessive and unwanted body hair ranges in severity and can usually be classified as either hypertrichosis or hirsutism.

The desired clinical endpoint is perifollicular edema and erythema. Treatment parameters that can be varied with Food and Drug Administration–cleared devices include wavelength, fluence, pulse duration, spot size, and skin cooling. The most popular devices are the Alexandrite 755 nm laser; the diode 800 nm laser; and the 1064 nm Nd:YAG laser, which is safe for all skin types. “Often you have to use higher relative fluences to treat patients with the 1064 nm Nd:YAG because on the absorption spectrum, the 1064-nm wavelength has a relatively lower absorption for melanin compared to the alexandrite. However, you can still get effective, long-term hair reduction with the Nd:YAG laser,” he said (Arch Dermatol. 2008 Oct;144[10]:1323-7).

More recently, Dr. Ibrahimi and colleagues found that a 1060-nm diode laser system with multiple handpieces for permanent hair reduction was safe for all skin types, in an open label prospective study.

Higher fluences have been correlated with greater rates of permanent hair removal, but they also are more likely to cause undesired side effects. Dr. Ibrahimi advises clinicians new to laser hair removal to conduct a few different test spots and look for the desired clinical endpoint of perifollicular erythema and edema. “The highest fluence that gives you that endpoint without any adverse reactions is going to the best fluence for treatment,” he said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Do a few test spots, bring them back a week later and see which ones were tolerated well without any side effects and which weren’t. That gives you a good starting point for your treatment.”

Cooling down the epidermal melanin not only keeps the procedure safe, it’s a salve for pain. “There are a variety of methods of passive and active cooling,” said Dr. Ibrahimi, a member of the American Society for Dermatologic Surgery board of directors. “You can use something as simple as cold gel, but the active methods are better because once the method of passive application of cold gel warms up, you lose that cooling effect. You can use forced chilled air. Many commercial devices come with a cold tip which cools down the epidermal melanin. Others use dynamic cooling, which emit cryogen spray from a separate part of the handpiece. It hits right where the laser pulse is going to go, is absorbed by the skin, and it cools down the epidermal melanin.”


 

Treatment complications

Complications that can occur from treatment include pigmentary changes such as hyperpigmentation and hypopigmentation. “In lighter skinned individuals, sometimes excess fluence can lead to an erythematous appearance,” he said. “In darker-skinned individuals, this often manifests as hyperpigmentation and can be very long-lasting.” Dr. Ibrahimi ranks improper technique as a complication, “because ideally you want to lay your pulses down with 10%-15% overlap during treatment,” he explained. “If you don’t overlap, you’re going to have zones that don’t get any of the laser photons. If you do, then your patient is not going to be happy with you.”

Paradoxical hypertrichosis occurs in 1%-5% of patients, typically in women from Mediterranean, Middle Eastern, or South Asian ethnic backgrounds. This tends to develop on the lateral or jawline part of the face. “Often it occurs in the setting where they come in and want these vellus hairs treated,” he said. “Somehow the laser, instead of destroying the hair shaft, triggers it and stimulates it and can’t differentiate a vellus hair from a terminal hair. This is important to discuss during your informed consent, especially when you’re treating on the lateral jawline or the sideburn area. If this happens, you can treat through it.”

Transgender patients and future directions

Dr. Ibrahimi pointed out that increasing numbers of transgender patients are visiting dermatologists seeking laser hair removal. About 16 million Americans are estimated to have a gender identity that differs from the one assigned to them at birth, yet they face several barriers to care, “ranging from ignorance on our end to maybe our own biases being transposed onto these patients,” he said. “We really need to do a better job for them. We really have an obligation to provide good care for all of our patients.”

Transgender women typically seek hair removal on the face and neck as well as in the genital area to remove hairs in preparation for vaginoplasty. Transgender men typically seek hair reduction on the forearm or on the thigh, because those are graft sites in preparation for phalloplasty. As a resource for transgender care, he recommends the UCSF Transgender Care website.

As for future directions in the field, Dr. Ibrahimi predicted that hair removal devices for home use will continue to improve and become more widespread. “This raises a host of considerations, from the risk of eye damage to the risk for paradoxical hypertrichosis, and what happens when pigmented lesions get treated with these low-powered machines compared to the ones we have in our office,” he said. “I also think we’re going to see office-based devices with larger spot sizes, smarter devices that are capable of taking over more of the functions we do. I’m most excited about the potential for treating nonpigmented white hair or poorly pigmented blond or reddish hair in the future.”

Dr. Ibrahimi disclosed that he has received research funding and speaker honoraria from Lutronic, Lumenis, Cutera, and Syneron-Candela. He also holds stock in AVAVA Inc.

dbrunk@mdedge.com

Omar A. Ibrahimi, MD, PhD, hears some dermatology colleagues say they don’t bother to offer laser hair removal in their practices because they figure that the procedure is under the purview of medical spas, but he sees it differently.

“I offer laser hair removal in my practice as a way to protect my patients from being picked off by medical spas,” Dr. Ibrahimi, a dermatologist and medical director of the Connecticut Skin Institute, said during a virtual course on laser and aesthetic skin therapy. “These patients are going to want to get laser hair removal. If they’re not going to have the opportunity to get it at your practice, they’re going to seek it elsewhere. When they go elsewhere, they’re going to be picked off for other procedures as well.”

First developed in 1995 by R. Rox Anderson, MD, and colleagues at The Wellman Center for Photomedicine, laser hair removal has become the gold standard for permanent hair destruction, and ranks as the most common energy-based procedure performed in the world, Dr. Ibrahimi said. “Results are very long lasting and durable beyond 2 years after treatment,” he said. “These patients tend to be highly satisfied and have permanence with these treatments.”
 

Treatment goal, patient selection

While the target chromophore for the procedure is melanin, the goal is to destroy the stem cells located in the hair bulge and the hair bulb. “This is technically called the extended theory of selective photothermolysis, but it’s the same concept except that our target chromophore and our desired target for destruction are slightly spatially separated,” he said.

Proper patient selection is key, so a focused medical history and physical exam are essential prior to the procedure. If unwanted hair is located on the face, jawline, or chest of a female, consider and ask about potential endocrine-related dysfunctions such as polycystic ovary syndrome (PCOS). “Getting those addressed can often help the hypertrichosis as well,” he said. “Another condition is explosive hypertrichosis where hair growth starts very suddenly. It’s uncommon but it’s something to think about.”

Pregnancy is not an absolute contraindication for laser hair removal, Dr. Ibrahimi continued, but he elects not to perform the procedure on pregnant patients. He also asks patients about any history of photosensitivity, active infection at the intended treatment site, keloids, or hypertrophic scarring. Past methods of hair removal also matter. “What we’re targeting is the pigment in the hair shafts,” he said. “So, if your patient is waxing or plucking or epilating or removing the hair in some manner, they’re actually removing the target chromophore.”

Patients with darker Fitzpatrick skin types can be treated safely but tanned individuals face a risk of complications because of active melanocytes. “As we approach summer in New England, we slow down the amount of hair removal we do because it’s a riskier procedure,” he said. “I recommend that my patients not get any significant amount of sun exposure a month before or after treatment.”

The color and quality of hair also drive treatment success. Black and brown terminal hairs absorb the millisecond laser energy, but white, gray, red, and light blond hairs lack adequate melanin to make them suitable target chromophores.

Excessive and unwanted body hair ranges in severity and can usually be classified as either hypertrichosis or hirsutism.

The desired clinical endpoint is perifollicular edema and erythema. Treatment parameters that can be varied with Food and Drug Administration–cleared devices include wavelength, fluence, pulse duration, spot size, and skin cooling. The most popular devices are the Alexandrite 755 nm laser; the diode 800 nm laser; and the 1064 nm Nd:YAG laser, which is safe for all skin types. “Often you have to use higher relative fluences to treat patients with the 1064 nm Nd:YAG because on the absorption spectrum, the 1064-nm wavelength has a relatively lower absorption for melanin compared to the alexandrite. However, you can still get effective, long-term hair reduction with the Nd:YAG laser,” he said (Arch Dermatol. 2008 Oct;144[10]:1323-7).

More recently, Dr. Ibrahimi and colleagues found that a 1060-nm diode laser system with multiple handpieces for permanent hair reduction was safe for all skin types, in an open label prospective study.

Higher fluences have been correlated with greater rates of permanent hair removal, but they also are more likely to cause undesired side effects. Dr. Ibrahimi advises clinicians new to laser hair removal to conduct a few different test spots and look for the desired clinical endpoint of perifollicular erythema and edema. “The highest fluence that gives you that endpoint without any adverse reactions is going to the best fluence for treatment,” he said at the meeting, which was named “Laser & Aesthetic Skin Therapy: What’s the Truth” and was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “Do a few test spots, bring them back a week later and see which ones were tolerated well without any side effects and which weren’t. That gives you a good starting point for your treatment.”

Cooling down the epidermal melanin not only keeps the procedure safe, it’s a salve for pain. “There are a variety of methods of passive and active cooling,” said Dr. Ibrahimi, a member of the American Society for Dermatologic Surgery board of directors. “You can use something as simple as cold gel, but the active methods are better because once the method of passive application of cold gel warms up, you lose that cooling effect. You can use forced chilled air. Many commercial devices come with a cold tip which cools down the epidermal melanin. Others use dynamic cooling, which emit cryogen spray from a separate part of the handpiece. It hits right where the laser pulse is going to go, is absorbed by the skin, and it cools down the epidermal melanin.”


 

Treatment complications

Complications that can occur from treatment include pigmentary changes such as hyperpigmentation and hypopigmentation. “In lighter skinned individuals, sometimes excess fluence can lead to an erythematous appearance,” he said. “In darker-skinned individuals, this often manifests as hyperpigmentation and can be very long-lasting.” Dr. Ibrahimi ranks improper technique as a complication, “because ideally you want to lay your pulses down with 10%-15% overlap during treatment,” he explained. “If you don’t overlap, you’re going to have zones that don’t get any of the laser photons. If you do, then your patient is not going to be happy with you.”

Paradoxical hypertrichosis occurs in 1%-5% of patients, typically in women from Mediterranean, Middle Eastern, or South Asian ethnic backgrounds. This tends to develop on the lateral or jawline part of the face. “Often it occurs in the setting where they come in and want these vellus hairs treated,” he said. “Somehow the laser, instead of destroying the hair shaft, triggers it and stimulates it and can’t differentiate a vellus hair from a terminal hair. This is important to discuss during your informed consent, especially when you’re treating on the lateral jawline or the sideburn area. If this happens, you can treat through it.”

Transgender patients and future directions

Dr. Ibrahimi pointed out that increasing numbers of transgender patients are visiting dermatologists seeking laser hair removal. About 16 million Americans are estimated to have a gender identity that differs from the one assigned to them at birth, yet they face several barriers to care, “ranging from ignorance on our end to maybe our own biases being transposed onto these patients,” he said. “We really need to do a better job for them. We really have an obligation to provide good care for all of our patients.”

Transgender women typically seek hair removal on the face and neck as well as in the genital area to remove hairs in preparation for vaginoplasty. Transgender men typically seek hair reduction on the forearm or on the thigh, because those are graft sites in preparation for phalloplasty. As a resource for transgender care, he recommends the UCSF Transgender Care website.

As for future directions in the field, Dr. Ibrahimi predicted that hair removal devices for home use will continue to improve and become more widespread. “This raises a host of considerations, from the risk of eye damage to the risk for paradoxical hypertrichosis, and what happens when pigmented lesions get treated with these low-powered machines compared to the ones we have in our office,” he said. “I also think we’re going to see office-based devices with larger spot sizes, smarter devices that are capable of taking over more of the functions we do. I’m most excited about the potential for treating nonpigmented white hair or poorly pigmented blond or reddish hair in the future.”

Dr. Ibrahimi disclosed that he has received research funding and speaker honoraria from Lutronic, Lumenis, Cutera, and Syneron-Candela. He also holds stock in AVAVA Inc.

dbrunk@mdedge.com

Cosmeceutical alternatives to hydroquinone, which is now restricted in the United States from inclusion in over-the-counter (OTC) products, are proliferating, along with new strategies to improve their efficacy, according to a report at the Skin of Color Update 2021.

“Ten or 15 years ago, I was showing a slide with five [alternatives to hydroquinone]. Now there are dozens,” reported Heather Woolery-Lloyd, MD, director of the skin of color division in the department of dermatology at the University of Miami.

The growth in alternatives to hydroquinone is timely. After threats to do so for more than a decade, the Food and Drug Administration finally banned hydroquinone from OTC products in 2020. The ban was folded into the Coronavirus Aid, Relief, and Economic Security (CARES) Act passed in March of 2020 and then implemented the following September.

Until the ban of hydroquinone, OTC products with this compound were widely sought by many individuals with darker skin tones to self-treat melasma and other forms of hyperpigmentation, according to Dr. Woolery-Lloyd. Hydroquinone is still available in prescription products, but she is often asked for OTC alternatives, and she says the list is long and getting longer.
 

Niacinamide

Detailing the products she has been recommending most frequently as substitutes, Dr. Woolery-Lloyd reported that several are supported by high quality studies. One example is niacinamide.

Of the several controlled studies she cited, one double-blind randomized trial found niacinamide to be equivalent to hydroquinone for melasma on the basis of colorimetric measures. The study compared 4% niacinamide cream applied on one side of the face with 4% hydroquinone cream applied on the other side in 27 patients with melasma. Although the proportion of responses rated good or excellent on a subjective basis was lower with niacinamide (44% vs. 55%), the difference was not statistically significant and niacinamide cream was clearly active, producing objective improvements in mast cell infiltrate and solar elastosis in melasma skin as well. Both were well tolerated.

In other studies, niacinamide has been shown to be effective in the treatment of melasma when combined with other active agents such as tranexamic acid, said Dr. Woolery-Lloyd, who added that OTC products containing niacinamide are now “among my favorites” when directing patients to cosmeceuticals for hyperpigmentation.
 

Topical vitamin C

Topical vitamin C or ascorbic acid is another. Like niacinamide, topical vitamin C has also been compared with hydroquinone in a double-blind, randomized trial. Although the niacinamide trial and this study were performed 10 or more years ago, these data have new relevance with the ban of OTC hydroquinone.

In the study, 5% ascorbic acid cream on one side of the face was compared with 4% hydroquinone cream, applied on the other side, in 16 women with melasma. Again, there were no statistical differences in colorimetric measures, but good to excellent results were reported for 93% of the sides of the face treated with hydroquinone versus 62.5% of the sides treated with vitamin C (P < .05). “Hydroquinone performed better, but the vitamin C was active and very well tolerated,” Dr. Woolery-Lloyd said.

However, the ascorbic acid cream was better tolerated, with a far lower rate of adverse events (6.2% vs. 68.7%), an advantage that makes it easy to recommend to patients, said Dr. Woolery-Lloyd, who now uses it frequently in her own practice.

Liquiritin, a licorice extract, is another lightening agent increasingly included in OTC products that she also recommends. In two older studies in medical journals published in Pakistan, both the 2% and 4% strengths of liquiritin cream outperformed hydroquinone on the basis of a Melasma Area and Severity Index (MASI) rating. The liquiritin cream was well tolerated in both studies.


 

Azelaic acid, tranexamic acid

OTC products containing azelaic acid are also effective for hyperpigmentation based on published trials in which they were compared with hydroquinone for treating melasma. In one study of 29 women with melasma cited by Dr. Woolery-Lloyd, 20% azelaic acid cream was more effective than hydroquinone 4% cream after 2 months of treatment on the basis of the mean MASI score (6.2 vs. 3.8).

The list also includes cysteamine, silymarin, and tranexamic acid.

In the case of tranexamic acid, Dr. Woolery-Lloyd cited a relatively recent study of 60 patients with melasma, comparing two strategies for applying tranexamic acid to treatment with hydroquinone over 12 weeks. Compared with 2% hydroquinone (applied nightly) or 1.8% liposomal tranexamic acid (applied twice a day), 5% tranexamic acid solution with microneedling (weekly) had a slightly greater rate of success defined as more than a 50% improvement in hyperpigmentation in an Asian population (30%, 27.8%, and 33.3%, respectively).

“Microneedling is a newer technology that appears to be effective at improving absorption,” said Dr. Woolery-Lloyd. She predicts that microneedling will be used with increasing frequency in combination with topical cosmeceuticals.

She also predicted that these topical agents will be increasingly employed in combinations as the field of cosmeceuticals becomes increasingly more sophisticated. “When it comes to skin quality, cosmeceuticals remain our first-line therapy, especially in skin of color,” she said.

The rapid growth and utility of OTC cosmeceuticals is an area that dermatologists need to be following, according to Darius Mehregan, MD, chair of the department of dermatology, Wayne State University, Detroit, who was senior author of an article published last year that reviewed the ingredients of popular OTC cosmeceuticals.

“Our patients have a great interest in cosmeceuticals and are looking to us for guidance. I think we have a responsibility to help them identify products supported by evidence and to warn them about potential side effects,” Dr. Mehregan, who was not at the meeting, said in an interview.

He agreed that the removal of hydroquinone from OTC products will create a specific need in the area of cosmeceuticals.

“Hydroquinone has for a long time been one of the most effective agents in OTC products for melasma, so patients are going to be looking for alternatives. Identifying which drugs have shown efficacy in controlled studies will be very helpful,” he said.

Dr. Woolery-Lloyd reports financial relationships with Ortho Dermatologics, L’Oréal, Galderma, Allergan, and Somabella Laboratories. Dr. Mehregan reports no potential conflicts of interest.

Cosmeceutical alternatives to hydroquinone, which is now restricted in the United States from inclusion in over-the-counter (OTC) products, are proliferating, along with new strategies to improve their efficacy, according to a report at the Skin of Color Update 2021.

“Ten or 15 years ago, I was showing a slide with five [alternatives to hydroquinone]. Now there are dozens,” reported Heather Woolery-Lloyd, MD, director of the skin of color division in the department of dermatology at the University of Miami.

The growth in alternatives to hydroquinone is timely. After threats to do so for more than a decade, the Food and Drug Administration finally banned hydroquinone from OTC products in 2020. The ban was folded into the Coronavirus Aid, Relief, and Economic Security (CARES) Act passed in March of 2020 and then implemented the following September.

Until the ban of hydroquinone, OTC products with this compound were widely sought by many individuals with darker skin tones to self-treat melasma and other forms of hyperpigmentation, according to Dr. Woolery-Lloyd. Hydroquinone is still available in prescription products, but she is often asked for OTC alternatives, and she says the list is long and getting longer.
 

Niacinamide

Detailing the products she has been recommending most frequently as substitutes, Dr. Woolery-Lloyd reported that several are supported by high quality studies. One example is niacinamide.

Of the several controlled studies she cited, one double-blind randomized trial found niacinamide to be equivalent to hydroquinone for melasma on the basis of colorimetric measures. The study compared 4% niacinamide cream applied on one side of the face with 4% hydroquinone cream applied on the other side in 27 patients with melasma. Although the proportion of responses rated good or excellent on a subjective basis was lower with niacinamide (44% vs. 55%), the difference was not statistically significant and niacinamide cream was clearly active, producing objective improvements in mast cell infiltrate and solar elastosis in melasma skin as well. Both were well tolerated.

In other studies, niacinamide has been shown to be effective in the treatment of melasma when combined with other active agents such as tranexamic acid, said Dr. Woolery-Lloyd, who added that OTC products containing niacinamide are now “among my favorites” when directing patients to cosmeceuticals for hyperpigmentation.
 

Topical vitamin C

Topical vitamin C or ascorbic acid is another. Like niacinamide, topical vitamin C has also been compared with hydroquinone in a double-blind, randomized trial. Although the niacinamide trial and this study were performed 10 or more years ago, these data have new relevance with the ban of OTC hydroquinone.

In the study, 5% ascorbic acid cream on one side of the face was compared with 4% hydroquinone cream, applied on the other side, in 16 women with melasma. Again, there were no statistical differences in colorimetric measures, but good to excellent results were reported for 93% of the sides of the face treated with hydroquinone versus 62.5% of the sides treated with vitamin C (P < .05). “Hydroquinone performed better, but the vitamin C was active and very well tolerated,” Dr. Woolery-Lloyd said.

However, the ascorbic acid cream was better tolerated, with a far lower rate of adverse events (6.2% vs. 68.7%), an advantage that makes it easy to recommend to patients, said Dr. Woolery-Lloyd, who now uses it frequently in her own practice.

Liquiritin, a licorice extract, is another lightening agent increasingly included in OTC products that she also recommends. In two older studies in medical journals published in Pakistan, both the 2% and 4% strengths of liquiritin cream outperformed hydroquinone on the basis of a Melasma Area and Severity Index (MASI) rating. The liquiritin cream was well tolerated in both studies.


 

Azelaic acid, tranexamic acid

OTC products containing azelaic acid are also effective for hyperpigmentation based on published trials in which they were compared with hydroquinone for treating melasma. In one study of 29 women with melasma cited by Dr. Woolery-Lloyd, 20% azelaic acid cream was more effective than hydroquinone 4% cream after 2 months of treatment on the basis of the mean MASI score (6.2 vs. 3.8).

The list also includes cysteamine, silymarin, and tranexamic acid.

In the case of tranexamic acid, Dr. Woolery-Lloyd cited a relatively recent study of 60 patients with melasma, comparing two strategies for applying tranexamic acid to treatment with hydroquinone over 12 weeks. Compared with 2% hydroquinone (applied nightly) or 1.8% liposomal tranexamic acid (applied twice a day), 5% tranexamic acid solution with microneedling (weekly) had a slightly greater rate of success defined as more than a 50% improvement in hyperpigmentation in an Asian population (30%, 27.8%, and 33.3%, respectively).

“Microneedling is a newer technology that appears to be effective at improving absorption,” said Dr. Woolery-Lloyd. She predicts that microneedling will be used with increasing frequency in combination with topical cosmeceuticals.

She also predicted that these topical agents will be increasingly employed in combinations as the field of cosmeceuticals becomes increasingly more sophisticated. “When it comes to skin quality, cosmeceuticals remain our first-line therapy, especially in skin of color,” she said.

The rapid growth and utility of OTC cosmeceuticals is an area that dermatologists need to be following, according to Darius Mehregan, MD, chair of the department of dermatology, Wayne State University, Detroit, who was senior author of an article published last year that reviewed the ingredients of popular OTC cosmeceuticals.

“Our patients have a great interest in cosmeceuticals and are looking to us for guidance. I think we have a responsibility to help them identify products supported by evidence and to warn them about potential side effects,” Dr. Mehregan, who was not at the meeting, said in an interview.

He agreed that the removal of hydroquinone from OTC products will create a specific need in the area of cosmeceuticals.

“Hydroquinone has for a long time been one of the most effective agents in OTC products for melasma, so patients are going to be looking for alternatives. Identifying which drugs have shown efficacy in controlled studies will be very helpful,” he said.

Dr. Woolery-Lloyd reports financial relationships with Ortho Dermatologics, L’Oréal, Galderma, Allergan, and Somabella Laboratories. Dr. Mehregan reports no potential conflicts of interest.

Cosmeceutical alternatives to hydroquinone, which is now restricted in the United States from inclusion in over-the-counter (OTC) products, are proliferating, along with new strategies to improve their efficacy, according to a report at the Skin of Color Update 2021.

“Ten or 15 years ago, I was showing a slide with five [alternatives to hydroquinone]. Now there are dozens,” reported Heather Woolery-Lloyd, MD, director of the skin of color division in the department of dermatology at the University of Miami.

The growth in alternatives to hydroquinone is timely. After threats to do so for more than a decade, the Food and Drug Administration finally banned hydroquinone from OTC products in 2020. The ban was folded into the Coronavirus Aid, Relief, and Economic Security (CARES) Act passed in March of 2020 and then implemented the following September.

Until the ban of hydroquinone, OTC products with this compound were widely sought by many individuals with darker skin tones to self-treat melasma and other forms of hyperpigmentation, according to Dr. Woolery-Lloyd. Hydroquinone is still available in prescription products, but she is often asked for OTC alternatives, and she says the list is long and getting longer.
 

Niacinamide

Detailing the products she has been recommending most frequently as substitutes, Dr. Woolery-Lloyd reported that several are supported by high quality studies. One example is niacinamide.

Of the several controlled studies she cited, one double-blind randomized trial found niacinamide to be equivalent to hydroquinone for melasma on the basis of colorimetric measures. The study compared 4% niacinamide cream applied on one side of the face with 4% hydroquinone cream applied on the other side in 27 patients with melasma. Although the proportion of responses rated good or excellent on a subjective basis was lower with niacinamide (44% vs. 55%), the difference was not statistically significant and niacinamide cream was clearly active, producing objective improvements in mast cell infiltrate and solar elastosis in melasma skin as well. Both were well tolerated.

In other studies, niacinamide has been shown to be effective in the treatment of melasma when combined with other active agents such as tranexamic acid, said Dr. Woolery-Lloyd, who added that OTC products containing niacinamide are now “among my favorites” when directing patients to cosmeceuticals for hyperpigmentation.
 

Topical vitamin C

Topical vitamin C or ascorbic acid is another. Like niacinamide, topical vitamin C has also been compared with hydroquinone in a double-blind, randomized trial. Although the niacinamide trial and this study were performed 10 or more years ago, these data have new relevance with the ban of OTC hydroquinone.

In the study, 5% ascorbic acid cream on one side of the face was compared with 4% hydroquinone cream, applied on the other side, in 16 women with melasma. Again, there were no statistical differences in colorimetric measures, but good to excellent results were reported for 93% of the sides of the face treated with hydroquinone versus 62.5% of the sides treated with vitamin C (P < .05). “Hydroquinone performed better, but the vitamin C was active and very well tolerated,” Dr. Woolery-Lloyd said.

However, the ascorbic acid cream was better tolerated, with a far lower rate of adverse events (6.2% vs. 68.7%), an advantage that makes it easy to recommend to patients, said Dr. Woolery-Lloyd, who now uses it frequently in her own practice.

Liquiritin, a licorice extract, is another lightening agent increasingly included in OTC products that she also recommends. In two older studies in medical journals published in Pakistan, both the 2% and 4% strengths of liquiritin cream outperformed hydroquinone on the basis of a Melasma Area and Severity Index (MASI) rating. The liquiritin cream was well tolerated in both studies.


 

Azelaic acid, tranexamic acid

OTC products containing azelaic acid are also effective for hyperpigmentation based on published trials in which they were compared with hydroquinone for treating melasma. In one study of 29 women with melasma cited by Dr. Woolery-Lloyd, 20% azelaic acid cream was more effective than hydroquinone 4% cream after 2 months of treatment on the basis of the mean MASI score (6.2 vs. 3.8).

The list also includes cysteamine, silymarin, and tranexamic acid.

In the case of tranexamic acid, Dr. Woolery-Lloyd cited a relatively recent study of 60 patients with melasma, comparing two strategies for applying tranexamic acid to treatment with hydroquinone over 12 weeks. Compared with 2% hydroquinone (applied nightly) or 1.8% liposomal tranexamic acid (applied twice a day), 5% tranexamic acid solution with microneedling (weekly) had a slightly greater rate of success defined as more than a 50% improvement in hyperpigmentation in an Asian population (30%, 27.8%, and 33.3%, respectively).

“Microneedling is a newer technology that appears to be effective at improving absorption,” said Dr. Woolery-Lloyd. She predicts that microneedling will be used with increasing frequency in combination with topical cosmeceuticals.

She also predicted that these topical agents will be increasingly employed in combinations as the field of cosmeceuticals becomes increasingly more sophisticated. “When it comes to skin quality, cosmeceuticals remain our first-line therapy, especially in skin of color,” she said.

The rapid growth and utility of OTC cosmeceuticals is an area that dermatologists need to be following, according to Darius Mehregan, MD, chair of the department of dermatology, Wayne State University, Detroit, who was senior author of an article published last year that reviewed the ingredients of popular OTC cosmeceuticals.

“Our patients have a great interest in cosmeceuticals and are looking to us for guidance. I think we have a responsibility to help them identify products supported by evidence and to warn them about potential side effects,” Dr. Mehregan, who was not at the meeting, said in an interview.

He agreed that the removal of hydroquinone from OTC products will create a specific need in the area of cosmeceuticals.

“Hydroquinone has for a long time been one of the most effective agents in OTC products for melasma, so patients are going to be looking for alternatives. Identifying which drugs have shown efficacy in controlled studies will be very helpful,” he said.

Dr. Woolery-Lloyd reports financial relationships with Ortho Dermatologics, L’Oréal, Galderma, Allergan, and Somabella Laboratories. Dr. Mehregan reports no potential conflicts of interest.