Dermatology

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

More than a week after the rollout of the new, gender-neutral approach to the risk mitigation program for isotretinoin, frustration and glitches are still an issue, according to dermatologists, pharmacists, and patients.

When the new website and call center launched Dec. 13, hours-long hold times and repeated crashing of the website were reported as the norm, not the exception, triggering the American Academy of Dermatology Association (AADA) to request – and get – an emergency meeting on Dec. 16 with the U.S. Food and Drug Administration, which mandates the risk evaluation and mitigation strategy (REMS) for isotretinoin due to the teratogenicity of the acne medication.

At that meeting, ‘’the FDA and HHS [U.S. Department of Health and Human Services] acknowledged the concerns of dermatologists and the need for stakeholders to work collaboratively to find a solution,” Ilona Frieden, MD, chair of the AADA’s iPLEDGE workgroup and professor of dermatology at the University of California, San Francisco, said in an email interview. At the meeting, the AADA representatives described the severe impact on patient access to treatment that is resulting from the issues. The AADA also ‘’reiterated our call for a temporary pause to the program while stakeholders work to resolve the urgent issues with the platform,” she said.

The new approach, which is intended to make the experience more inclusive for transgender patients, reduces the previous three risk categories (females of reproductive potential, females not of reproductive potential, and males) to just two (those capable of getting pregnant and those not capable). The program requires physicians, patients, and pharmacists who prescribe, use, or dispense the drug to be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by patients capable of becoming pregnant.

With reduced or no access during the technology glitches, access to the medicine was delayed for some patients. And dermatologists, pharmacists, and their staffs reported grueling hold times trying to reach the call center when the website had issues.

While the FDA agreed to help find a solution, it noted that the solution ‘’was to be found with dermatologists and pharmacists who are on the ground living the program every day,” Dr. Frieden said. No timeline for solving the issues was provided, so on Dec. 21, the AADA asked the FDA for a constructive dialogue among stakeholders within the next 24 hours, Dr. Frieden told this news organization.

While Dr. Frieden sees progress, ‘’we are disappointed that this situation continues to drag on for more than a week later, with more patients losing access to their needed medication each day.” While some prescribers have been able to log onto the portal and enter the information required, confirming some patients, large gaps remain, she said. Patients and pharmacists still report difficulties logging on. When that happens and they try to reach the call center, there are often hours-long hold times, dropped calls, or a message saying to call back.

The iPLEDGE administrator is Syneos Health, but a spokesperson for Syneos, Gary Gatyas, said the company does not maintain the system or the contact center.

So who does manage the call center and website? “The AADA has asked stakeholders, including Syneos Health, for clarification on who manages the call center and website but has not received a response,” Dr. Frieden said. “In the meeting [Dec. 16], representatives from the FDA made clear that the iPLEDGE sponsors are ultimately responsible for this REMS program,” Dr. Frieden said.

According to the FDA, isotretinoin manufacturers are part of the iPLEDGE program. On the iPLEDGE website, 12 isotretinoin products are listed, made by eight different companies.

One dermatologist maneuvering the new website who registered successfully as a provider told this news organization that he received a follow-up survey from United BioSource about the new website. This news organization contacted that company to confirm it runs the website but has not yet received a response.

Meanwhile, dermatologists continue to help frustrated patients cope with the new website and registration details. Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, heard from two mothers who helped their teen daughters complete the forms by attesting they would use abstinence as contraception but then couldn’t figure out how to answer another question. As a result, their answers were interpreted as the patients saying they were using abstinence but didn’t commit to not having sexual contact with a partner capable of impregnating them. So Dr. Goldberg got an automated message back from the iPLEDGE program that the answers were a mismatch.

And in the comments section following a previous story on the problematic rollout, one reader offered a suggestion for reducing hold times to the call center: choose the Spanish option.

Dr. Frieden and Dr. Goldberg have no relevant disclosures.

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

The gradual development of a rash in an area of frequent direct contact between metal and skin is pathognomonic for allergic contact dermatitis (ACD). Contact dermatitis often results from exposure to metals. Stainless steel is a group of ferrous alloys composed of a variety of elements including nickel, which is added to increase corrosion resistance. Unfortunately, nickel is a metal commonly known to induce a delayed hypersensitivity response. In the upper left corner of the image shown here, one can see the metal plate of the watch band.

ACD is a T-cell mediated, delayed, type IV hypersensitivity response to foreign materials.¹ These reactions typically occur around 48 to 72 hours following contact with the metal but can take weeks to appear, depending on the amount of T-cell activation. Symptoms may appear more rapidly on repeat exposures. Lesions manifest as erythematous, scaly plaques, which may include vesicles and bullae in severe cases.

The mainstay of treatment for allergic contact dermatitis is avoidance of the allergen once it has been identified. Nickel is commonly found in metal parts on clothing and in jewelry. One method of protection from nickel in these cases is to cover the metal that touches the skin with a clear nail polish or another clear barrier (commercial options are available). Duct tape or fabric can also be used to cover the metal.

Topical corticosteroids are the first-line therapy to treat lesions. Topical calcineurin inhibitors are an alternative. Systemic corticosteroids may be indicated if there is extensive body surface area involvement. Phototherapy or systemic immunosuppression may be considered in severe refractory cases.

Our patient was counseled on the nature of the disease process and educated on strategies to avoid future exposures. Treatment was initiated with topical triamcinolone 0.1% ointment with follow-up as needed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Spenser Squire, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

The gradual development of a rash in an area of frequent direct contact between metal and skin is pathognomonic for allergic contact dermatitis (ACD). Contact dermatitis often results from exposure to metals. Stainless steel is a group of ferrous alloys composed of a variety of elements including nickel, which is added to increase corrosion resistance. Unfortunately, nickel is a metal commonly known to induce a delayed hypersensitivity response. In the upper left corner of the image shown here, one can see the metal plate of the watch band.

ACD is a T-cell mediated, delayed, type IV hypersensitivity response to foreign materials.¹ These reactions typically occur around 48 to 72 hours following contact with the metal but can take weeks to appear, depending on the amount of T-cell activation. Symptoms may appear more rapidly on repeat exposures. Lesions manifest as erythematous, scaly plaques, which may include vesicles and bullae in severe cases.

The mainstay of treatment for allergic contact dermatitis is avoidance of the allergen once it has been identified. Nickel is commonly found in metal parts on clothing and in jewelry. One method of protection from nickel in these cases is to cover the metal that touches the skin with a clear nail polish or another clear barrier (commercial options are available). Duct tape or fabric can also be used to cover the metal.

Topical corticosteroids are the first-line therapy to treat lesions. Topical calcineurin inhibitors are an alternative. Systemic corticosteroids may be indicated if there is extensive body surface area involvement. Phototherapy or systemic immunosuppression may be considered in severe refractory cases.

Our patient was counseled on the nature of the disease process and educated on strategies to avoid future exposures. Treatment was initiated with topical triamcinolone 0.1% ointment with follow-up as needed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Spenser Squire, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

The gradual development of a rash in an area of frequent direct contact between metal and skin is pathognomonic for allergic contact dermatitis (ACD). Contact dermatitis often results from exposure to metals. Stainless steel is a group of ferrous alloys composed of a variety of elements including nickel, which is added to increase corrosion resistance. Unfortunately, nickel is a metal commonly known to induce a delayed hypersensitivity response. In the upper left corner of the image shown here, one can see the metal plate of the watch band.

ACD is a T-cell mediated, delayed, type IV hypersensitivity response to foreign materials.¹ These reactions typically occur around 48 to 72 hours following contact with the metal but can take weeks to appear, depending on the amount of T-cell activation. Symptoms may appear more rapidly on repeat exposures. Lesions manifest as erythematous, scaly plaques, which may include vesicles and bullae in severe cases.

The mainstay of treatment for allergic contact dermatitis is avoidance of the allergen once it has been identified. Nickel is commonly found in metal parts on clothing and in jewelry. One method of protection from nickel in these cases is to cover the metal that touches the skin with a clear nail polish or another clear barrier (commercial options are available). Duct tape or fabric can also be used to cover the metal.

Topical corticosteroids are the first-line therapy to treat lesions. Topical calcineurin inhibitors are an alternative. Systemic corticosteroids may be indicated if there is extensive body surface area involvement. Phototherapy or systemic immunosuppression may be considered in severe refractory cases.

Our patient was counseled on the nature of the disease process and educated on strategies to avoid future exposures. Treatment was initiated with topical triamcinolone 0.1% ointment with follow-up as needed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Spenser Squire, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

The frequency of showering or bathing and follow-up application of moisturizer appear to be more important factors associated with atopic dermatitis (AD) severity than the duration of showers or baths, results from a prospective observational study found.

Uros Rakita

“Patients may benefit most from counseling on showering or bathing once daily and regularly applying moisturizer after showering or bathing,” one of the study authors, Uros Rakita, MSc, told this news organization. “Recommending less than daily shower frequencies or counseling on specific shower durations may not be necessary.”

During a late-breaking abstract session at the Revolutionizing Atopic Dermatitis symposium, Mr. Rakita, a fourth-year student at Chicago Medical School, North Chicago, presented findings from a prospective, practice-based dermatology study that investigated the longitudinal relationship between different bathing practices and AD severity to help inform patient counseling about optimal bathing practices.

“AD is a chronic, inflammatory skin condition with a diverse set of environmental triggers and exacerbating factors,” Mr. Rakita said during the meeting. “Maintaining adequate skin hydration, skin hygiene, and avoiding triggers are key aspects of AD management across all disease severities. Therefore, understanding optimal shower or bath and moisturizing practices is essential.” In fact, he added, “bathing has been shown to not only hydrate the skin, but also to improve symptoms, remove allergens, and decrease [Staphylococcus] aureus colonization. However, at the same time, concern exists for the potential of inappropriate shower or bathing frequency or durations, as well as inconsistent moisturizer application to worsen disease severity and potentially compromise disease management.”

He noted that current guidelines on bathing frequency and duration among AD patients lack consensus, are limited, and are largely based on studies of pediatric populations.

Mr. Rakita, along with primary study author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, and Trisha Kaundinya, a medical student at Northwestern University, Chicago, prospectively evaluated 509 adults with AD who made an average of 2.3 visits at a single dermatology clinic between 2013 and 2020. At each visit, severity of AD signs and symptoms, as well as bathing and moisturizing practices, were assessed.

AD severity was assessed using the objective component of Scoring Atopic Dermatitis (o-SCORAD), intensity of pruritus in the past 3 days (SCORAD-itch), Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). The researchers constructed repeated measures regression models to examine associations of bathing and moisturizing practices with change in AD severity outcome measure scores over time. Multivariable models controlled for age, sex, and race.

In adjusted linear regression models, showering or bathing more than once a day versus once daily was associated with significantly higher scores for SCORAD-itch (0.74; P = .0456), o-SCORAD (4.27; P = .0171), EASI (4.20; P = .0028), POEM (2.61; P = .0021), and DLQI (2.77; P = .0004).

The researchers also found that consistent application of moisturizer after the shower or bath was associated with significantly lower scores for o-SCORAD (–7.22; P < .0001), EASI (–3.91; P = .001) and POEM (–2.68; P = .0002), compared against not applying moisturizer after a shower or bath. However, shower or bath duration of more than, compared against fewer than, 15 minutes was not associated with significantly lower scores for o-SCORAD (1.26; P = .2868), SCORAD-itch (0.17; P = .4987), EASI (0.85; P = .3454), POEM (0.24; P = .6627) or DLQI (–0.40; P = .4318).

“Interestingly, this pattern was present when the reference shower or bath durations were under 10 minutes as well as under 5 minutes,” Mr. Rakita said. “Also, shower or bath frequencies of less than daily, relative to daily frequencies, were not significantly related to longitudinal AD severity.”

Mr. Rakita acknowledged certain limitations of the study, including the fact that the researchers did not examine the potential influence of specific soap and moisturizing products, water hardness, or other bathing features such as water temperature and bath additives.

Lawrence J. Green, MD, who was asked to comment on the study, said that he was not surprised by the finding that moisturizing after bathing improved AD signs and symptoms. “On the other hand, a long-held belief that longer duration of shower/bath time worsens AD was not found to be true,” said Dr. Green, a dermatologist who practices in Rockville, Md., and is also clinical professor of dermatology at George Washington University.

“This provides useful information for practicing dermatologists who wish to provide evidenced-based education about moisturizing and bathing to their AD patients,” he said.

The study was supported by the Agency for Healthcare Research and Quality and the Dermatology Foundation. Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies. There were no other disclosures.

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

Patients ages 65 years and older with atopic dermatitis (AD) have similar disease severity when compared with younger adult patients, but they have more profound sleep disturbances, especially trouble staying asleep.

Those are key findings from a cross-sectional study that Jaya Manjunath, BS, and Jonathan I. Silverberg, MD, PhD, MPH, presented during a poster session at the Revolutionizing Atopic Dermatitis symposium.

“Atopic dermatitis is a chronic, pruritic skin disease associated with sleep disturbance and fatigue affecting adults of all ages,” they wrote. “When caring for geriatric patients, several factors such as sleep disturbance, polypharmacy, cognition, social support, and mobility should be considered. However, little is known about the characteristics of atopic dermatitis in the geriatric population.”

Ms. Manjunath, a student at George Washington University, Washington, and Dr. Silverberg, director of clinical research in the department of dermatology at GWU, recruited patients with AD aged 18 years and older diagnosed by Hanifin-Rajka criteria who were evaluated at an academic medical center between 2014 and 2019. They underwent full body skin exams and completed electronic questionnaires. AD severity was assessed with the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD) total and itch subscores, Investigator’s Global Assessment (IGA), patient-reported Global Assessment of AD severity, and the Patient-Oriented Eczema Measure (POEM).

The researchers also assessed the frequency of sleep disturbances, including difficulty falling asleep and staying asleep, and used multivariable logistic regression models to evaluate associations of age (65 and older vs. 18-64 years) with AD severity, sleep disturbance or fatigue, controlling for total POEM score, sex, and race.

Using adjusted odds ratios, Ms. Manjunath and Dr. Silverberg found that being 65 or older was not associated with AD severity on the EASI (adjusted odds ratio, 1.47); total SCORAD (aOR, 1.10), and itch subscore (aOR, 1.00); IGA (aOR, 1.87); patient-reported Global Assessment of AD severity (aOR, 0.80), or the patient-oriented eczema measure (aOR, 0.55), associations that were not statistically significant.

However, the researchers found that older adult age was associated with an increased number of nights of sleep disturbance from AD in the past week (aOR, 2.14; P = .0142), as well as increased fatigue in the past 7 days (aOR, 1.81; P = .0313), trouble sleeping in the past 7 days (aOR, 1.98; P = .0118), and trouble staying asleep in the past 7 days (aOR, 2.26; P = .0030), but not with difficulty falling asleep in the last 7 days (aOR, 1.16; P = .5996).

“Future studies are needed to determine why geriatric AD patients have increased sleep disturbance and optimal interventions to address their sleep disturbance,” the researchers concluded.

The study was supported by the Agency for Healthcare Research and Quality, the Dermatology Foundation, and by an unrestricted grant from Galderma. Ms. Manjunath disclosed no relevant financial relationships. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.

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

Patients ages 65 years and older with atopic dermatitis (AD) have similar disease severity when compared with younger adult patients, but they have more profound sleep disturbances, especially trouble staying asleep.

Those are key findings from a cross-sectional study that Jaya Manjunath, BS, and Jonathan I. Silverberg, MD, PhD, MPH, presented during a poster session at the Revolutionizing Atopic Dermatitis symposium.

“Atopic dermatitis is a chronic, pruritic skin disease associated with sleep disturbance and fatigue affecting adults of all ages,” they wrote. “When caring for geriatric patients, several factors such as sleep disturbance, polypharmacy, cognition, social support, and mobility should be considered. However, little is known about the characteristics of atopic dermatitis in the geriatric population.”

Ms. Manjunath, a student at George Washington University, Washington, and Dr. Silverberg, director of clinical research in the department of dermatology at GWU, recruited patients with AD aged 18 years and older diagnosed by Hanifin-Rajka criteria who were evaluated at an academic medical center between 2014 and 2019. They underwent full body skin exams and completed electronic questionnaires. AD severity was assessed with the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD) total and itch subscores, Investigator’s Global Assessment (IGA), patient-reported Global Assessment of AD severity, and the Patient-Oriented Eczema Measure (POEM).

The researchers also assessed the frequency of sleep disturbances, including difficulty falling asleep and staying asleep, and used multivariable logistic regression models to evaluate associations of age (65 and older vs. 18-64 years) with AD severity, sleep disturbance or fatigue, controlling for total POEM score, sex, and race.

Using adjusted odds ratios, Ms. Manjunath and Dr. Silverberg found that being 65 or older was not associated with AD severity on the EASI (adjusted odds ratio, 1.47); total SCORAD (aOR, 1.10), and itch subscore (aOR, 1.00); IGA (aOR, 1.87); patient-reported Global Assessment of AD severity (aOR, 0.80), or the patient-oriented eczema measure (aOR, 0.55), associations that were not statistically significant.

However, the researchers found that older adult age was associated with an increased number of nights of sleep disturbance from AD in the past week (aOR, 2.14; P = .0142), as well as increased fatigue in the past 7 days (aOR, 1.81; P = .0313), trouble sleeping in the past 7 days (aOR, 1.98; P = .0118), and trouble staying asleep in the past 7 days (aOR, 2.26; P = .0030), but not with difficulty falling asleep in the last 7 days (aOR, 1.16; P = .5996).

“Future studies are needed to determine why geriatric AD patients have increased sleep disturbance and optimal interventions to address their sleep disturbance,” the researchers concluded.

The study was supported by the Agency for Healthcare Research and Quality, the Dermatology Foundation, and by an unrestricted grant from Galderma. Ms. Manjunath disclosed no relevant financial relationships. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.

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

Patients ages 65 years and older with atopic dermatitis (AD) have similar disease severity when compared with younger adult patients, but they have more profound sleep disturbances, especially trouble staying asleep.

Those are key findings from a cross-sectional study that Jaya Manjunath, BS, and Jonathan I. Silverberg, MD, PhD, MPH, presented during a poster session at the Revolutionizing Atopic Dermatitis symposium.

“Atopic dermatitis is a chronic, pruritic skin disease associated with sleep disturbance and fatigue affecting adults of all ages,” they wrote. “When caring for geriatric patients, several factors such as sleep disturbance, polypharmacy, cognition, social support, and mobility should be considered. However, little is known about the characteristics of atopic dermatitis in the geriatric population.”

Ms. Manjunath, a student at George Washington University, Washington, and Dr. Silverberg, director of clinical research in the department of dermatology at GWU, recruited patients with AD aged 18 years and older diagnosed by Hanifin-Rajka criteria who were evaluated at an academic medical center between 2014 and 2019. They underwent full body skin exams and completed electronic questionnaires. AD severity was assessed with the Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD) total and itch subscores, Investigator’s Global Assessment (IGA), patient-reported Global Assessment of AD severity, and the Patient-Oriented Eczema Measure (POEM).

The researchers also assessed the frequency of sleep disturbances, including difficulty falling asleep and staying asleep, and used multivariable logistic regression models to evaluate associations of age (65 and older vs. 18-64 years) with AD severity, sleep disturbance or fatigue, controlling for total POEM score, sex, and race.

Using adjusted odds ratios, Ms. Manjunath and Dr. Silverberg found that being 65 or older was not associated with AD severity on the EASI (adjusted odds ratio, 1.47); total SCORAD (aOR, 1.10), and itch subscore (aOR, 1.00); IGA (aOR, 1.87); patient-reported Global Assessment of AD severity (aOR, 0.80), or the patient-oriented eczema measure (aOR, 0.55), associations that were not statistically significant.

However, the researchers found that older adult age was associated with an increased number of nights of sleep disturbance from AD in the past week (aOR, 2.14; P = .0142), as well as increased fatigue in the past 7 days (aOR, 1.81; P = .0313), trouble sleeping in the past 7 days (aOR, 1.98; P = .0118), and trouble staying asleep in the past 7 days (aOR, 2.26; P = .0030), but not with difficulty falling asleep in the last 7 days (aOR, 1.16; P = .5996).

“Future studies are needed to determine why geriatric AD patients have increased sleep disturbance and optimal interventions to address their sleep disturbance,” the researchers concluded.

The study was supported by the Agency for Healthcare Research and Quality, the Dermatology Foundation, and by an unrestricted grant from Galderma. Ms. Manjunath disclosed no relevant financial relationships. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

The ophthalmologist credited with developing botulinum toxin (Botox) for medical use has died at the age of 89, his family confirmed to National Public Radio.

Four decades ago, Alan Brown Scott, MD, a native of Berkeley, Calif., turned the drug, once a deadly poison, into a revolutionary treatment for obscure eye diseases. It later became a well-known blockbuster treatment for reducing the appearance of wrinkles and treating hyperhidrosis (excessive sweating). Other approved medical uses include treatment of overactive bladder and urinary incontinence.

According to the American Society of Plastic Surgeons, its popularity for cosmetic use was boosted further during the pandemic and it was the No. 1 minimally invasive cosmetic procedure performed in 2020. Among the 13.3 million procedures, 4.4 million involved Botox.

According to Bloomberg Businessweek, Ed Schantz, who was working in the military’s biological weapons program, was the one to first send the toxin to Dr. Scott, who wanted to explore its properties for medical use.

The same Bloomberg article also noted that the original botulinum toxin itself “is so powerful that a tiny amount can suffocate a person by paralyzing the muscles used for breathing.”

Dr. Scott was looking for a way to help his patients avoid extensive surgeries.

“Specifically, he was aiming to treat people with strabismus, or cross-eyes, and blepharospasm, which is an uncontrollable closure of eyes. Today, it’s also used as a treatment to help with migraines, hair loss, and drooling,” NPR reported.

The New York Times once described Botox as “medicine’s answer to duct tape.”

Dr. Scott was the executive director of the Smith-Kettlewell Eye Research Institute in San Francisco when he did his pioneering research with botulinum toxin in the 1970s and 1980s, according to a 2002 article in SFGate.

In 1991, Dr. Scott sold the drug to Allergan, when it was called Oculinum. The next year, the name was officially changed to Botox.

In 2002, Dr. Scott told SFGate, when asked about the more popular use for the drug, “I think that’s a charming, slightly frivolous use,” adding, “but it’s not along the lines of what I was into, applications for serious disorders.”

According to Scientific American in 2016, Dr. Scott, then age 83, kept working on the noncosmetic benefits of botulism-toxin injections for eye-related disorders at the Strabismus Research Foundation,

He told Scientific American he was proud that his efforts “are directly helpful to people.”

“There are interesting and difficult problems still to be solved, and I’m a practicing physician and I see them every day,” he said.

Dr. Scott’s daughter, Ann Scott, told NPR: “He definitely loved his work and he was also a really great father.” She said her dad involved his children in his research and work.

She added, “He was a really calm, more of a quiet reserved person,” and said he was committed to teaching his students, many of them international students.

“That was what he really loved,” she said.

Dr. Scott, who died Dec. 16, was in intensive care for the last 10 days from an unspecified illness, his daughter told NPR.

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

A cluster analysis of circulating plasma biomarkers in prurigo nodularis (PN) has identified two disease endotypes with inflammatory and noninflammatory biomarker profiles.

The findings confirm clinical observations of disease heterogeneity, and highlight that PN “involves a spectrum of neuroimmune dysfunction, where patients can be at either end of the spectrum [toward either immune or neural dysregulation],” said senior author Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore. “This is the beginning of personalized medicine in prurigo nodularis.”

He and others have long observed significant clinical heterogeneity both in the presentation of PN – with the nodules in African American patients, for instance, appearing larger, thicker, and more fibrotic – and in patients’ response to immunomodulating and neuromodulating therapies.

To avoid the introduction of bias, the researchers used an unsupervised machine-learning approach to analyze the levels of 12 inflammatory biomarkers in 20 patients with PN and in matched healthy controls. The biomarkers were chosen based on their demonstrated dysregulation in PN and other inflammatory dermatoses.

The researchers then conducted a population-level analysis using multicenter electronic medical record data to explore inflammatory markers and verify findings from the cluster analysis. The study was published online Oct. 27, 2021, in the Journal of Investigative Dermatology.

One cluster of the 20 patients had higher levels of nine inflammatory biomarkers representing multiple immune axes: Higher interleukin-1 alpha, IL-4, IL-5, IL-6, IL-10, IL-17A, IL-22, and IL-25. This cluster had a higher percentage of Black patients, a higher severity of itch, and lower quality of life scores, the authors report in the preprint.

The other cluster – without such an inflammatory profile – had fewer Black patients and a higher percentage of patients with myelopathy (e.g. spinal stenosis, spinal trauma, degenerative disc disease). The rates of inflammatory comorbidities and of immune- and neuromodulating treatments at the time of blood draw were relatively equivalent between the two clusters.

In the subsequent population-level analysis, using data from a global health research network of EMRs from almost 50 health care organizations, Black patients with PN were found to have higher erythrocyte sedimentation rate, C-reactive protein, ferritin, and eosinophils, and lower transferrin, than White patients with PN. (The analysis included only Black and White patients.)

There are no Food and Drug Administration–approved therapies for PN, and “clinicians need to be really creative in managing these patients,” Dr. Kwatra said.

“There may be suggestions at the bedside that patients have more immune dysregulation, or maybe I’ll see increased circulating blood eosinophils,” he said. “And there are those who don’t seem to have any immune dysregulation and have more features of neurosensitization ... who may have a history of neck pain or back injury.”

The existence of endotypes in PN suggests that patients may benefit from personalized therapies with either immunomodulating or neuromodulating treatments, he and his colleagues wrote. “Further neuroimmune phenotyping studies of PN may pave the way for a future precision medicine management approach.”

Studies of PN conducted in Europe have been almost exclusively in White patients, Dr. Kwatra noted, even though PN has been shown to disproportionately affect Black and other racial/ethnic-minority patients.

Black patients with PN were found to have the highest all-cause mortality over 20 years post diagnosis in a separate analysis of over 22,000 patients with PN. Using data from the same health research network, Dr. Kwatra and coinvestigators stratified patients by race/ethnicity and compared each subgroup with a corresponding subgroup of similar race/ethnicity to control for inherent differences in mortality.

Overall, patients with PN had higher all-cause mortality than controls (hazard ratio, 1.70), likely because of a high comorbidity burden, they wrote in their research letter. Black patients with PN had the highest mortality (HR, 2.07), followed by White (HR, 1.74) and Hispanic (HR, 1.62) patients.

PN may exacerbate existing racial disparities in the social determinants of health, and Black patients may suffer from greater systemic inflammation, Dr. Kwatra and coauthors wrote. Certainly, he said, these findings, as well as the finding of a distinct inflammatory signature in Black patients with PN, support “that the disease burden is much higher” in these patients.

Dr Kwatra disclosed that he is an advisory board member/consultant for Celldex Therapeutics, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals and has received grant funding from several companies. His research is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grants from the Dermatology Foundation and the Skin of Color Society also helped fund the cluster analysis.

A cluster analysis of circulating plasma biomarkers in prurigo nodularis (PN) has identified two disease endotypes with inflammatory and noninflammatory biomarker profiles.

The findings confirm clinical observations of disease heterogeneity, and highlight that PN “involves a spectrum of neuroimmune dysfunction, where patients can be at either end of the spectrum [toward either immune or neural dysregulation],” said senior author Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore. “This is the beginning of personalized medicine in prurigo nodularis.”

He and others have long observed significant clinical heterogeneity both in the presentation of PN – with the nodules in African American patients, for instance, appearing larger, thicker, and more fibrotic – and in patients’ response to immunomodulating and neuromodulating therapies.

To avoid the introduction of bias, the researchers used an unsupervised machine-learning approach to analyze the levels of 12 inflammatory biomarkers in 20 patients with PN and in matched healthy controls. The biomarkers were chosen based on their demonstrated dysregulation in PN and other inflammatory dermatoses.

The researchers then conducted a population-level analysis using multicenter electronic medical record data to explore inflammatory markers and verify findings from the cluster analysis. The study was published online Oct. 27, 2021, in the Journal of Investigative Dermatology.

One cluster of the 20 patients had higher levels of nine inflammatory biomarkers representing multiple immune axes: Higher interleukin-1 alpha, IL-4, IL-5, IL-6, IL-10, IL-17A, IL-22, and IL-25. This cluster had a higher percentage of Black patients, a higher severity of itch, and lower quality of life scores, the authors report in the preprint.

The other cluster – without such an inflammatory profile – had fewer Black patients and a higher percentage of patients with myelopathy (e.g. spinal stenosis, spinal trauma, degenerative disc disease). The rates of inflammatory comorbidities and of immune- and neuromodulating treatments at the time of blood draw were relatively equivalent between the two clusters.

In the subsequent population-level analysis, using data from a global health research network of EMRs from almost 50 health care organizations, Black patients with PN were found to have higher erythrocyte sedimentation rate, C-reactive protein, ferritin, and eosinophils, and lower transferrin, than White patients with PN. (The analysis included only Black and White patients.)

There are no Food and Drug Administration–approved therapies for PN, and “clinicians need to be really creative in managing these patients,” Dr. Kwatra said.

“There may be suggestions at the bedside that patients have more immune dysregulation, or maybe I’ll see increased circulating blood eosinophils,” he said. “And there are those who don’t seem to have any immune dysregulation and have more features of neurosensitization ... who may have a history of neck pain or back injury.”

The existence of endotypes in PN suggests that patients may benefit from personalized therapies with either immunomodulating or neuromodulating treatments, he and his colleagues wrote. “Further neuroimmune phenotyping studies of PN may pave the way for a future precision medicine management approach.”

Studies of PN conducted in Europe have been almost exclusively in White patients, Dr. Kwatra noted, even though PN has been shown to disproportionately affect Black and other racial/ethnic-minority patients.

Black patients with PN were found to have the highest all-cause mortality over 20 years post diagnosis in a separate analysis of over 22,000 patients with PN. Using data from the same health research network, Dr. Kwatra and coinvestigators stratified patients by race/ethnicity and compared each subgroup with a corresponding subgroup of similar race/ethnicity to control for inherent differences in mortality.

Overall, patients with PN had higher all-cause mortality than controls (hazard ratio, 1.70), likely because of a high comorbidity burden, they wrote in their research letter. Black patients with PN had the highest mortality (HR, 2.07), followed by White (HR, 1.74) and Hispanic (HR, 1.62) patients.

PN may exacerbate existing racial disparities in the social determinants of health, and Black patients may suffer from greater systemic inflammation, Dr. Kwatra and coauthors wrote. Certainly, he said, these findings, as well as the finding of a distinct inflammatory signature in Black patients with PN, support “that the disease burden is much higher” in these patients.

Dr Kwatra disclosed that he is an advisory board member/consultant for Celldex Therapeutics, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals and has received grant funding from several companies. His research is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grants from the Dermatology Foundation and the Skin of Color Society also helped fund the cluster analysis.

A cluster analysis of circulating plasma biomarkers in prurigo nodularis (PN) has identified two disease endotypes with inflammatory and noninflammatory biomarker profiles.

The findings confirm clinical observations of disease heterogeneity, and highlight that PN “involves a spectrum of neuroimmune dysfunction, where patients can be at either end of the spectrum [toward either immune or neural dysregulation],” said senior author Shawn G. Kwatra, MD, of the department of dermatology at Johns Hopkins University, Baltimore. “This is the beginning of personalized medicine in prurigo nodularis.”

He and others have long observed significant clinical heterogeneity both in the presentation of PN – with the nodules in African American patients, for instance, appearing larger, thicker, and more fibrotic – and in patients’ response to immunomodulating and neuromodulating therapies.

To avoid the introduction of bias, the researchers used an unsupervised machine-learning approach to analyze the levels of 12 inflammatory biomarkers in 20 patients with PN and in matched healthy controls. The biomarkers were chosen based on their demonstrated dysregulation in PN and other inflammatory dermatoses.

The researchers then conducted a population-level analysis using multicenter electronic medical record data to explore inflammatory markers and verify findings from the cluster analysis. The study was published online Oct. 27, 2021, in the Journal of Investigative Dermatology.

One cluster of the 20 patients had higher levels of nine inflammatory biomarkers representing multiple immune axes: Higher interleukin-1 alpha, IL-4, IL-5, IL-6, IL-10, IL-17A, IL-22, and IL-25. This cluster had a higher percentage of Black patients, a higher severity of itch, and lower quality of life scores, the authors report in the preprint.

The other cluster – without such an inflammatory profile – had fewer Black patients and a higher percentage of patients with myelopathy (e.g. spinal stenosis, spinal trauma, degenerative disc disease). The rates of inflammatory comorbidities and of immune- and neuromodulating treatments at the time of blood draw were relatively equivalent between the two clusters.

In the subsequent population-level analysis, using data from a global health research network of EMRs from almost 50 health care organizations, Black patients with PN were found to have higher erythrocyte sedimentation rate, C-reactive protein, ferritin, and eosinophils, and lower transferrin, than White patients with PN. (The analysis included only Black and White patients.)

There are no Food and Drug Administration–approved therapies for PN, and “clinicians need to be really creative in managing these patients,” Dr. Kwatra said.

“There may be suggestions at the bedside that patients have more immune dysregulation, or maybe I’ll see increased circulating blood eosinophils,” he said. “And there are those who don’t seem to have any immune dysregulation and have more features of neurosensitization ... who may have a history of neck pain or back injury.”

The existence of endotypes in PN suggests that patients may benefit from personalized therapies with either immunomodulating or neuromodulating treatments, he and his colleagues wrote. “Further neuroimmune phenotyping studies of PN may pave the way for a future precision medicine management approach.”

Studies of PN conducted in Europe have been almost exclusively in White patients, Dr. Kwatra noted, even though PN has been shown to disproportionately affect Black and other racial/ethnic-minority patients.

Black patients with PN were found to have the highest all-cause mortality over 20 years post diagnosis in a separate analysis of over 22,000 patients with PN. Using data from the same health research network, Dr. Kwatra and coinvestigators stratified patients by race/ethnicity and compared each subgroup with a corresponding subgroup of similar race/ethnicity to control for inherent differences in mortality.

Overall, patients with PN had higher all-cause mortality than controls (hazard ratio, 1.70), likely because of a high comorbidity burden, they wrote in their research letter. Black patients with PN had the highest mortality (HR, 2.07), followed by White (HR, 1.74) and Hispanic (HR, 1.62) patients.

PN may exacerbate existing racial disparities in the social determinants of health, and Black patients may suffer from greater systemic inflammation, Dr. Kwatra and coauthors wrote. Certainly, he said, these findings, as well as the finding of a distinct inflammatory signature in Black patients with PN, support “that the disease burden is much higher” in these patients.

Dr Kwatra disclosed that he is an advisory board member/consultant for Celldex Therapeutics, Galderma, Incyte, Pfizer, Regeneron, and Kiniksa Pharmaceuticals and has received grant funding from several companies. His research is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grants from the Dermatology Foundation and the Skin of Color Society also helped fund the cluster analysis.

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

dbrunk@mdedge.com

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

dbrunk@mdedge.com

There is an increased incidence of locally staged Merkel cell carcinoma (MCC) among patients who live in rural areas of the United States, compared with those in urban and metropolitan areas, yet overall survival is worse in rural areas.

This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.

“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”

The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.

A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”

Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.

Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”

The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.

dbrunk@mdedge.com

The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

dermnews@mdedge.com

The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

dermnews@mdedge.com

The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

dermnews@mdedge.com

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

The Food and Drug Administration is convening an emergency meeting Dec. 16 with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed rollout of the new, gender-neutral approach to the isotretinoin risk mitigation program that launched on Dec. 13, and what can be done to fix it.

By most accounts, the rollout was disastrous, chaotic, and a failure. Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary halt to the program until the bugs can be ironed out.

On Twitter Dec. 15, the Academy posted: “Due to the unacceptable situation with #iPLEDGE, the @US_FDA has convened an emergency meeting with AADA representatives tomorrow, December 16.”

The switch to a new platform was met with frustration from physicians, pharmacists, and patients alike. The new website crashed repeatedly, with physicians and patients complaining they got locked out or bounced off the platform when they attempted to follow instructions to enter information. Calls to obtain support from a live person often required hours on hold, several said.

The new approach to the isotretinoin risk-mitigation program itself isn’t under fire. It was welcomed by dermatologists and others who had long requested the change. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), there are now two (those who can get pregnant and those who cannot). Advocates for the change said it will make the experience more inclusive for transgender patients. The previous categories, some contended, were a barrier to access to care.

Because isotretinoin (Absorica, Amnesteem, Claravis, others), an oral retinoid used to treat severe forms of acne, is teratogenic, with a high risk of birth defects, and has also been associated with other health issues, those who take the medication who are able to get pregnant must take contraceptive precautions. The risk evaluation and mitigation program (REMS), mandated by the FDA, stipulates that physicians, patients, and pharmacists prescribing, using, or dispensing the drug must all be registered with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by those capable of becoming pregnant.

A day of frustration

Before navigating the new website, a new log-on name was needed, said Ilona J. Frieden, MD, chair of the AADA’s iPLEDGE Workgroup and professor of dermatology at the University of California, San Francisco. “They made you create a month-day-year date of personal significance.” When she tried to log on, she got locked out, she said in an interview.

The transition from the old website to the new, which Dr. Frieden said is now administered by a different vendor, was done quickly. The previous website shut down Dec. 10, and the new one launched Dec. 13, the first day for the new approach.

“A slower rollout would have helped,” Dr. Frieden said. While she and other dermatologists said they offered input previously on how to make the transition go more smoothly, no one seemed to want that help. “We did have a listening session with the FDA,” Dr. Frieden said. That was before the scheduled meeting of Dec. 16.

Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, also was frustrated with the rollout. “The week before the transition, one of my staff had to call iPLEDGE. They had a 177-minute wait to get to a human.

“They want us to register patients online now instead of signing forms in the office, but the links to view, download, or print don’t work,” Dr. Goldberg said in an interview.

This was after receiving information from the iPLEDGE REMS program, which stated, “The iPLEDGE REMS website will be updated to a modernized platform. All program materials and educational tools will be now available to you at the click of a button.’’

Dr. Goldberg also received calls from three patients who reported that they couldn’t complete the quiz that is required of patients capable of reproducing to demonstrate their comprehension about risk. Without the completed quiz, required monthly, the prescription can’t be refilled.

“It’s chaotic,” said Howa Yeung, MD, assistant professor of dermatology at Emory University, Atlanta. “The change is sudden, it’s a major change in the workflow. The process of reverification [required] is not that hard, but a lot of people have trouble even logging into the platform.”

What would help? To have a human on the phone to help navigate the system, Dr. Yeung said.

The glitches are delaying prescriptions for established patients and new ones as well, Dr. Yeung said. Existing patients who can get pregnant have 7 days after their negative pregnancy test to get their prescription filled. “And over the weekend the website was down,” he said, so that was a 2-day delay.

“The information we have and were told to use doesn’t match what is in their database,” said Mitesh Patel, PharmD, owner of Sunshine Pharmacy in White Plains, N.Y., who said pharmacists are experiencing issues with the new platform similar to those of doctors.

Twitter users had a lot to say, as well. Jack Resneck Jr., MD, professor of dermatology at the University of California, San Francisco, tweeted: “#Accutane has basically been pulled from market by utter incompetence of @SyneosHealth hired by @US_FDA to administer risk mgmt program.”

Dr. Resneck, president-elect of the American Medical Association, noted the crashed website, help line with 6-hour hold times, and patients unable to get the drug.

Adewole Adamson, MD, a dermatologist at the University of Texas, Austin, tweeted, “Dermatologists around the US are BIG mad about the current accutane debacle brought on by @SyneosHealth and @US_FDA. What a disaster for patient care!”

Are fixes in sight?

On Tuesday, Dec. 14, AADA President Kenneth J. Tomecki, MD, issued a statement expressing disappointment about the transition.

AAD

“In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator, Syneos Health, about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.”

The AADA, the statement continues, supports efforts to streamline the program while keeping patient safety and incorporating input from physicians.

“We are very aware of the problems with the implementation of the iPLEDGE program,” FDA spokesperson Charlie Kohler said in an email. “We are continuing to work closely with the isotretinoin manufacturers to ensure that they implement a smoothly functioning iPLEDGE REMS program and that patient care is not interrupted.”

“Syneos Health appreciates the concern about iPLEDGE,” said Gary Gatyas, a spokesperson for Syneos Health. “While Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties with a resolution.” Meanwhile, he recommended that people contact the call center.

He did not respond immediately to questions about who is responsible for maintaining the system and call center.

Dr. Goldberg, Dr. Frieden, and Dr. Yeung have disclosed no relevant financial relationships.

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

The Food and Drug Administration is convening an emergency meeting Dec. 16 with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed rollout of the new, gender-neutral approach to the isotretinoin risk mitigation program that launched on Dec. 13, and what can be done to fix it.

By most accounts, the rollout was disastrous, chaotic, and a failure. Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary halt to the program until the bugs can be ironed out.

On Twitter Dec. 15, the Academy posted: “Due to the unacceptable situation with #iPLEDGE, the @US_FDA has convened an emergency meeting with AADA representatives tomorrow, December 16.”

The switch to a new platform was met with frustration from physicians, pharmacists, and patients alike. The new website crashed repeatedly, with physicians and patients complaining they got locked out or bounced off the platform when they attempted to follow instructions to enter information. Calls to obtain support from a live person often required hours on hold, several said.

The new approach to the isotretinoin risk-mitigation program itself isn’t under fire. It was welcomed by dermatologists and others who had long requested the change. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), there are now two (those who can get pregnant and those who cannot). Advocates for the change said it will make the experience more inclusive for transgender patients. The previous categories, some contended, were a barrier to access to care.

Because isotretinoin (Absorica, Amnesteem, Claravis, others), an oral retinoid used to treat severe forms of acne, is teratogenic, with a high risk of birth defects, and has also been associated with other health issues, those who take the medication who are able to get pregnant must take contraceptive precautions. The risk evaluation and mitigation program (REMS), mandated by the FDA, stipulates that physicians, patients, and pharmacists prescribing, using, or dispensing the drug must all be registered with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by those capable of becoming pregnant.

A day of frustration

Before navigating the new website, a new log-on name was needed, said Ilona J. Frieden, MD, chair of the AADA’s iPLEDGE Workgroup and professor of dermatology at the University of California, San Francisco. “They made you create a month-day-year date of personal significance.” When she tried to log on, she got locked out, she said in an interview.

The transition from the old website to the new, which Dr. Frieden said is now administered by a different vendor, was done quickly. The previous website shut down Dec. 10, and the new one launched Dec. 13, the first day for the new approach.

“A slower rollout would have helped,” Dr. Frieden said. While she and other dermatologists said they offered input previously on how to make the transition go more smoothly, no one seemed to want that help. “We did have a listening session with the FDA,” Dr. Frieden said. That was before the scheduled meeting of Dec. 16.

Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, also was frustrated with the rollout. “The week before the transition, one of my staff had to call iPLEDGE. They had a 177-minute wait to get to a human.

“They want us to register patients online now instead of signing forms in the office, but the links to view, download, or print don’t work,” Dr. Goldberg said in an interview.

This was after receiving information from the iPLEDGE REMS program, which stated, “The iPLEDGE REMS website will be updated to a modernized platform. All program materials and educational tools will be now available to you at the click of a button.’’

Dr. Goldberg also received calls from three patients who reported that they couldn’t complete the quiz that is required of patients capable of reproducing to demonstrate their comprehension about risk. Without the completed quiz, required monthly, the prescription can’t be refilled.

“It’s chaotic,” said Howa Yeung, MD, assistant professor of dermatology at Emory University, Atlanta. “The change is sudden, it’s a major change in the workflow. The process of reverification [required] is not that hard, but a lot of people have trouble even logging into the platform.”

What would help? To have a human on the phone to help navigate the system, Dr. Yeung said.

The glitches are delaying prescriptions for established patients and new ones as well, Dr. Yeung said. Existing patients who can get pregnant have 7 days after their negative pregnancy test to get their prescription filled. “And over the weekend the website was down,” he said, so that was a 2-day delay.

“The information we have and were told to use doesn’t match what is in their database,” said Mitesh Patel, PharmD, owner of Sunshine Pharmacy in White Plains, N.Y., who said pharmacists are experiencing issues with the new platform similar to those of doctors.

Twitter users had a lot to say, as well. Jack Resneck Jr., MD, professor of dermatology at the University of California, San Francisco, tweeted: “#Accutane has basically been pulled from market by utter incompetence of @SyneosHealth hired by @US_FDA to administer risk mgmt program.”

Dr. Resneck, president-elect of the American Medical Association, noted the crashed website, help line with 6-hour hold times, and patients unable to get the drug.

Adewole Adamson, MD, a dermatologist at the University of Texas, Austin, tweeted, “Dermatologists around the US are BIG mad about the current accutane debacle brought on by @SyneosHealth and @US_FDA. What a disaster for patient care!”

Are fixes in sight?

On Tuesday, Dec. 14, AADA President Kenneth J. Tomecki, MD, issued a statement expressing disappointment about the transition.

AAD

“In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator, Syneos Health, about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.”

The AADA, the statement continues, supports efforts to streamline the program while keeping patient safety and incorporating input from physicians.

“We are very aware of the problems with the implementation of the iPLEDGE program,” FDA spokesperson Charlie Kohler said in an email. “We are continuing to work closely with the isotretinoin manufacturers to ensure that they implement a smoothly functioning iPLEDGE REMS program and that patient care is not interrupted.”

“Syneos Health appreciates the concern about iPLEDGE,” said Gary Gatyas, a spokesperson for Syneos Health. “While Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties with a resolution.” Meanwhile, he recommended that people contact the call center.

He did not respond immediately to questions about who is responsible for maintaining the system and call center.

Dr. Goldberg, Dr. Frieden, and Dr. Yeung have disclosed no relevant financial relationships.

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

The Food and Drug Administration is convening an emergency meeting Dec. 16 with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed rollout of the new, gender-neutral approach to the isotretinoin risk mitigation program that launched on Dec. 13, and what can be done to fix it.

By most accounts, the rollout was disastrous, chaotic, and a failure. Dermatologists on Twitter and elsewhere are angry and frustrated, with some calling for a temporary halt to the program until the bugs can be ironed out.

On Twitter Dec. 15, the Academy posted: “Due to the unacceptable situation with #iPLEDGE, the @US_FDA has convened an emergency meeting with AADA representatives tomorrow, December 16.”

The switch to a new platform was met with frustration from physicians, pharmacists, and patients alike. The new website crashed repeatedly, with physicians and patients complaining they got locked out or bounced off the platform when they attempted to follow instructions to enter information. Calls to obtain support from a live person often required hours on hold, several said.

The new approach to the isotretinoin risk-mitigation program itself isn’t under fire. It was welcomed by dermatologists and others who had long requested the change. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), there are now two (those who can get pregnant and those who cannot). Advocates for the change said it will make the experience more inclusive for transgender patients. The previous categories, some contended, were a barrier to access to care.

Because isotretinoin (Absorica, Amnesteem, Claravis, others), an oral retinoid used to treat severe forms of acne, is teratogenic, with a high risk of birth defects, and has also been associated with other health issues, those who take the medication who are able to get pregnant must take contraceptive precautions. The risk evaluation and mitigation program (REMS), mandated by the FDA, stipulates that physicians, patients, and pharmacists prescribing, using, or dispensing the drug must all be registered with requirements that include the use of two forms of an effective contraceptive and regular pregnancy tests by those capable of becoming pregnant.

A day of frustration

Before navigating the new website, a new log-on name was needed, said Ilona J. Frieden, MD, chair of the AADA’s iPLEDGE Workgroup and professor of dermatology at the University of California, San Francisco. “They made you create a month-day-year date of personal significance.” When she tried to log on, she got locked out, she said in an interview.

The transition from the old website to the new, which Dr. Frieden said is now administered by a different vendor, was done quickly. The previous website shut down Dec. 10, and the new one launched Dec. 13, the first day for the new approach.

“A slower rollout would have helped,” Dr. Frieden said. While she and other dermatologists said they offered input previously on how to make the transition go more smoothly, no one seemed to want that help. “We did have a listening session with the FDA,” Dr. Frieden said. That was before the scheduled meeting of Dec. 16.

Neil S. Goldberg, MD, a dermatologist in Westchester County, New York, also was frustrated with the rollout. “The week before the transition, one of my staff had to call iPLEDGE. They had a 177-minute wait to get to a human.

“They want us to register patients online now instead of signing forms in the office, but the links to view, download, or print don’t work,” Dr. Goldberg said in an interview.

This was after receiving information from the iPLEDGE REMS program, which stated, “The iPLEDGE REMS website will be updated to a modernized platform. All program materials and educational tools will be now available to you at the click of a button.’’

Dr. Goldberg also received calls from three patients who reported that they couldn’t complete the quiz that is required of patients capable of reproducing to demonstrate their comprehension about risk. Without the completed quiz, required monthly, the prescription can’t be refilled.

“It’s chaotic,” said Howa Yeung, MD, assistant professor of dermatology at Emory University, Atlanta. “The change is sudden, it’s a major change in the workflow. The process of reverification [required] is not that hard, but a lot of people have trouble even logging into the platform.”

What would help? To have a human on the phone to help navigate the system, Dr. Yeung said.

The glitches are delaying prescriptions for established patients and new ones as well, Dr. Yeung said. Existing patients who can get pregnant have 7 days after their negative pregnancy test to get their prescription filled. “And over the weekend the website was down,” he said, so that was a 2-day delay.

“The information we have and were told to use doesn’t match what is in their database,” said Mitesh Patel, PharmD, owner of Sunshine Pharmacy in White Plains, N.Y., who said pharmacists are experiencing issues with the new platform similar to those of doctors.

Twitter users had a lot to say, as well. Jack Resneck Jr., MD, professor of dermatology at the University of California, San Francisco, tweeted: “#Accutane has basically been pulled from market by utter incompetence of @SyneosHealth hired by @US_FDA to administer risk mgmt program.”

Dr. Resneck, president-elect of the American Medical Association, noted the crashed website, help line with 6-hour hold times, and patients unable to get the drug.

Adewole Adamson, MD, a dermatologist at the University of Texas, Austin, tweeted, “Dermatologists around the US are BIG mad about the current accutane debacle brought on by @SyneosHealth and @US_FDA. What a disaster for patient care!”

Are fixes in sight?

On Tuesday, Dec. 14, AADA President Kenneth J. Tomecki, MD, issued a statement expressing disappointment about the transition.

AAD

“In advance of this transition, the AADA engaged the FDA and the iPLEDGE administrator, Syneos Health, about the numerous workflow concerns raised by dermatologists and how the impending changes would threaten patient access to necessary medication. Those concerns have become a reality across the country and we’re working to ensure patients can maintain safe and appropriate access to the treatment they need.”

The AADA, the statement continues, supports efforts to streamline the program while keeping patient safety and incorporating input from physicians.

“We are very aware of the problems with the implementation of the iPLEDGE program,” FDA spokesperson Charlie Kohler said in an email. “We are continuing to work closely with the isotretinoin manufacturers to ensure that they implement a smoothly functioning iPLEDGE REMS program and that patient care is not interrupted.”

“Syneos Health appreciates the concern about iPLEDGE,” said Gary Gatyas, a spokesperson for Syneos Health. “While Syneos Health does not maintain the iPLEDGE system or contact center, we are doing what we can to help the responsible parties with a resolution.” Meanwhile, he recommended that people contact the call center.

He did not respond immediately to questions about who is responsible for maintaining the system and call center.

Dr. Goldberg, Dr. Frieden, and Dr. Yeung have disclosed no relevant financial relationships.

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