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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Axolotl Salamander Holds Potential for Cosmeceuticals, Wound Healing
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
For over 200 years, researchers have been captivated by axolotl salamanders (Ambystoma mexicanum) and their remarkable regenerative abilities, seeking to uncover secrets that could revolutionize regenerative medicine, including the scarless healing of wounds.
“The axolotl salamander is the most studied animal ever in science for its neotenic ability to regenerate,” Jill S. Waibel, MD, dermatologist and researcher in Miami, Florida, said in an interview. Neotenic tissue retains a juvenile or immature state throughout an organism’s life. In the case of the axolotl, “it can regenerate limbs, part of its heart, even its brain.”
A 2019 review of several studies on the regenerative abilities of axolotls highlights the importance of gene activity in controlling its skin regeneration. Specifically, growth factors such as fibroblast growth factors, transforming growth factor beta, and Wnt play a key role in guiding how the creature’s skin cells behave during healing and regrowth. The immune response , particularly the actions of macrophages and neutrophils, is also crucial in the early stages of regeneration, as these cells clear away dead tissue and kickstart the healing process.
without harming the animal. In axolotls, Waibel explained, damaged neotenic tissue “still thinks it’s in fetal mode, so if it injures its muscle, bone, nerves, collagen, or skin, everything will redevelop. After a few months in utero, that process stops in humans, but it never stops in the axolotl. The axolotl has scarless healing and immunity because of antimicrobial properties found in the neotenic tissue.”
RegenX scientists have developed a proprietary decellularization process that renders the urodele collagen extract safe and effective for use in humans. “We then harnessed a reservoir of bioactive peptides, which are small proteins that come from the axolotl, but they don’t contain any RNA or DNA that could confer the risk of any diseases or cancer,” she added.
According to Waibel, who is also subsection chief of dermatology at Baptist Hospital and past medical director of the Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic, genetic analysis of the axolotl revealed genes that have not been seen in humans. The urodele collagen extract also has anti-inflammatory and analgesic properties. “It decreases TNF [tumor necrosis factor] and IL [interleukin]–23 and stimulates regenerative pathways like FETUB (Fetuin-B), which is a gene involved in tissue regeneration,” she said. “We’re exploring these for some products.”
Institutional Review Board–approved human clinical trials at three US sites are nearly complete for evaluating an antiaging hydrating daily serum, an antiaging serum for damaged skin, and a restorative serum to be applied following cosmetic procedures, all containing the extract. The product furthest along is a “super gel” that contains properties of the urodele collagen extract.
In a proof-of-concept study using a third-degree burn model in two pigs, Waibel and colleagues at the University of Miami, found that 3 days after the injury was induced, application of the gel led to 92% reepithelialization of the pig’s skin, compared with only 54% in untreated skin.
Shortly after this study was conducted, a burn patient was referred to Waibel — 4 years after he was struck by lightning while fishing on a boat in Mississippi, an accident that resulted in the loss of his right arm and both legs. During a telemedicine consultation, Waibel noticed open ulcers on his chest. “What are those from?” she asked. “They’re from my accident 4 years ago,” he replied.
After the man flew to Miami for an in-person evaluation, Waibel treated his ulcers with a fractional laser to debride the wound, then applied the gel as part of a proof-of-concept approach, testing its potential in a real-world patient setting. Within 3 weeks, the long-standing ulcerated area had healed completely, marking the first time a human was treated with the super gel.
Looking ahead, the million-dollar question, Waibel noted, is how much healing can be achieved in humans with formulations of axolotl-derived technology. “For example, can we help a spinal cord injury patient? That sounds like a science fiction movie, but there are proteins in genes in this animal that we have turned off that potentially can be turned on in a human,” she said. “It’s very exciting.”
Arisa E. Ortiz, MD, director of Laser and Cosmetic Dermatology at the University of California, San Diego, and current president of the American Society for Laser Medicine and Surgery, who was asked to comment on this work, said that the use of urodele collagen extract derived from axolotl tissue “is an exciting innovation, especially given its unique properties like scarless healing and antimicrobial activity.”
While the results from preclinical and proof-of-concept studies are promising, “a key limitation lies in understanding the extent to which these findings will translate to human applications,” Ortiz said. “Overall, this research contributes significantly to the fields of regenerative medicine and dermatology, offering hope for more effective treatments in the future.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to provide her insights on the topic, said that, if researchers could replicate the axolotl salamander’s ability to regenerate its own limbs and organs, “medicine would be transformed. Rather than transplant another person’s organ with lifelong immunosuppression, a regenerative treatment could program a patient’s own body to create a needed organ.
“On a simpler level,” she continued, “regenerating skin and its underlying structures could hasten wound healing and potentially even treat hair loss. This is not a pipe dream, as Waibel has successfully treated severe ulcers using a super gel containing urodele collagen extract. Urodele collagen is type XII collagen, important in the salamander’s capacity to heal and regenerate.”
Waibel disclosed that she is a scientific adviser to RegenX and is a member of the company’s board of directors. Ortiz and Ko reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
Topical Tapinarof Approved for Treating Atopic Dermatitis, Ages 2 and Up
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
There Are ‘Four Pillars of Acne Pathogenesis’: Make Sure Treatment Hits as Many as Possible
LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.
“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”
In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”
She then discussed the best treatment options for each pillar:
Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.
Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.
Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.
C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.
Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.
In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”
In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.
Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.
A version of this article first appeared on Medscape.com.
LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.
“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”
In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”
She then discussed the best treatment options for each pillar:
Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.
Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.
Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.
C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.
Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.
In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”
In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.
Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.
A version of this article first appeared on Medscape.com.
LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.
“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”
In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”
She then discussed the best treatment options for each pillar:
Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.
Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.
Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.
C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.
Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.
In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”
In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.
Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.
A version of this article first appeared on Medscape.com.
FROM SDPA 2024
Treating Onychomycosis: Pearls from a Podiatrist
LAS VEGAS —
According to Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, most cases of onychomycosis are caused by the dermatophytes Trichophyton rubrum and T mentagrophytes, although the cause can also be a mixed infection. “Dermatophytes are going to impact the nails first, and molds may come in and join the party later,” she said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“The distal subungual onychomycosis (DSO) type is still the most common, but don’t forget that onychomycosis and nail psoriasis can happen at the same time. What we can’t lose sight of is that onychomycosis is a disease of the nail bed, which ultimately affects the nail plate; it’s not a disease of the nail plate first.”
Her diagnostic approach combines periodic acid-Schiff (PAS) staining with fungal culture “because I like to know the speciation,” she said. “PAS doesn’t give me the speciation; fungal cultures should. PCR can be expensive, but that can give me speciation.”
How Does This Happen?
Fungal DSO occurs because of exposure to a dermatophyte, which can be as simple as tinea pedis. “Perhaps it’s the environment in the shoe,” said Vlahovic, one of the authors of a textbook on onychomycosis. “That’s something I’m always concentrating on with the patient. What is your foot hygiene like? What’s your shoe and sock wear? What’s your level of physical activity? You can have trauma to the hyponychium, where the skin and the nail meet. Maybe they trim their nails too close to the skin, or maybe there’s another skin condition like psoriasis.”
The dermatophyte, she continued, enters and invades the nail at the hyponychium and uses the keratinase enzyme to digest keratin in the nail bed. Mild inflammation develops, and pH changes cause focal parakeratosis and subungual hyperkeratosis in the form of onycholysis and subungual debris. “Hyphae then invade the lamina of the nail plate, which causes brittle nails,” she said. “The compromised hyponychium creates a reservoir for molds and bacteria.”
Therapies approved by the Food and Drug Administration (FDA) for onychomycosis include the topical agents efinaconazole, tavaborole, and ciclopirox; the oral agents terbinafine and itraconazole; and laser therapy. Off-label, Vlahovic said that she sometimes uses oral fluconazole, pulsed dosing for terbinafine, and booster doses of terbinafine or any approved oral antifungal agent. Pulse dosing for itraconazole is FDA-approved for fingernails but not for toenails.
“We don’t have any oral antifungals that are approved for children, but we do have weight-based dosing,” she noted. Other off-label treatments for onychomycosis that patients may come across while browsing the internet but do not penetrate the nail plate, include products containing tolnaftate, tree oil, and undecylenic acid, “which is a very long-chain antifungal,” Vlahovic said. “It’s so huge that it can’t get through the nail plate. These products must get through the nail plate into the nail bed where the infection is.”
According to therapeutic recommendations for the treatment of toenail onychomycosis in the United States, published in 2021, terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. There are no current treatment recommendations for pregnant or lactating patients. “I always defer to the obstetrician,” said Vlahovic, a coauthor of the recommendations. For pediatric patients, there are approved topical medications: Efinaconazole and tavaborole for ages 6 and up and ciclopirox for ages 12 years or older.
Treatment recommendations for adults vary based on clinical presentation and patient characteristics. Questions to consider: Are they older? Do they have diabetes? Are they able to reach their feet to apply medication? What other medications are they taking? Are there any kidney or liver issues that are cause for concern?
Another question to consider is whether they have concurrent nail psoriasis. “When I have those patients, I often treat the onychomycosis first and the nail psoriasis second,” she said.
Evidence for Lasers Weak
Though laser therapy is FDA approved for the temporary increase of clear nails in onychomycosis, Vlahovic is underwhelmed by the evidence of its use for onychomycosis. According to a systematic review of 261 studies, only 1 reported treatment success as 16.7%, and clinical cures ranged from 13% to 16%. “Many of the existing studies were so poorly done in terms of protocols; it was frustrating,” she said. “No study has reported complete cure. There’s a lack of standardization across laser companies and a lack of standardization across protocols.”
Before starting oral antifungal therapy, Vlahovic uses the Onychomycosis Severity Index to determine the number of nails involved and the proportion of nails that are affected. She also wants to know if the patient is taking any medication that might interfere with an oral antifungal and gets baseline liver function tests (LFTs) to document results in the chart. “You want to discuss the pros and cons of oral antifungal therapy, and you want to set realistic expectations,” she added. “These medications are not cosmetic products; they are meant to kill fungus. Sometimes patients lose sight of that.”
Vlahovic routinely offers pulse dosing of terbinafine, which is FDA approved at a dose of 250 mg/d for 90 days. Pulse dosing involves taking terbinafine 250 mg twice a day for 1 week, followed by a 3-week break. This cycle is repeated three or four times. A clinical trial found no significant difference in outcome between patients who received pulsed vs continuous terbinafine dosing for the treatment of dermatophyte onychomycosis.
What About Oral Antifungal Safety?
For patients who ask about the safety of oral antifungals, Vlahovic characterized them as “well tolerated and safe in an immunocompetent population.” In a meta-analysis of 122 studies of about 22,000 patients, the pooled risk for treatment discontinuation because of adverse events was 3.4% for terbinafine 250 mg/d and 4.21% for itraconazole 200 mg/d. The risk for liver injury requiring termination of treatment and the risk of having symptomatic elevation of LFTs were less than 2% for all regimens.
According to the best available published evidence, Vlahovic said, the onychomycosis recurrence rate ranges from 6% to 40%. “That’s a wild number. We really have no idea what the true recurrence rate is, and that’s a problem.”
Vlahovic disclosed having been a consultant to and an investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
According to Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, most cases of onychomycosis are caused by the dermatophytes Trichophyton rubrum and T mentagrophytes, although the cause can also be a mixed infection. “Dermatophytes are going to impact the nails first, and molds may come in and join the party later,” she said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“The distal subungual onychomycosis (DSO) type is still the most common, but don’t forget that onychomycosis and nail psoriasis can happen at the same time. What we can’t lose sight of is that onychomycosis is a disease of the nail bed, which ultimately affects the nail plate; it’s not a disease of the nail plate first.”
Her diagnostic approach combines periodic acid-Schiff (PAS) staining with fungal culture “because I like to know the speciation,” she said. “PAS doesn’t give me the speciation; fungal cultures should. PCR can be expensive, but that can give me speciation.”
How Does This Happen?
Fungal DSO occurs because of exposure to a dermatophyte, which can be as simple as tinea pedis. “Perhaps it’s the environment in the shoe,” said Vlahovic, one of the authors of a textbook on onychomycosis. “That’s something I’m always concentrating on with the patient. What is your foot hygiene like? What’s your shoe and sock wear? What’s your level of physical activity? You can have trauma to the hyponychium, where the skin and the nail meet. Maybe they trim their nails too close to the skin, or maybe there’s another skin condition like psoriasis.”
The dermatophyte, she continued, enters and invades the nail at the hyponychium and uses the keratinase enzyme to digest keratin in the nail bed. Mild inflammation develops, and pH changes cause focal parakeratosis and subungual hyperkeratosis in the form of onycholysis and subungual debris. “Hyphae then invade the lamina of the nail plate, which causes brittle nails,” she said. “The compromised hyponychium creates a reservoir for molds and bacteria.”
Therapies approved by the Food and Drug Administration (FDA) for onychomycosis include the topical agents efinaconazole, tavaborole, and ciclopirox; the oral agents terbinafine and itraconazole; and laser therapy. Off-label, Vlahovic said that she sometimes uses oral fluconazole, pulsed dosing for terbinafine, and booster doses of terbinafine or any approved oral antifungal agent. Pulse dosing for itraconazole is FDA-approved for fingernails but not for toenails.
“We don’t have any oral antifungals that are approved for children, but we do have weight-based dosing,” she noted. Other off-label treatments for onychomycosis that patients may come across while browsing the internet but do not penetrate the nail plate, include products containing tolnaftate, tree oil, and undecylenic acid, “which is a very long-chain antifungal,” Vlahovic said. “It’s so huge that it can’t get through the nail plate. These products must get through the nail plate into the nail bed where the infection is.”
According to therapeutic recommendations for the treatment of toenail onychomycosis in the United States, published in 2021, terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. There are no current treatment recommendations for pregnant or lactating patients. “I always defer to the obstetrician,” said Vlahovic, a coauthor of the recommendations. For pediatric patients, there are approved topical medications: Efinaconazole and tavaborole for ages 6 and up and ciclopirox for ages 12 years or older.
Treatment recommendations for adults vary based on clinical presentation and patient characteristics. Questions to consider: Are they older? Do they have diabetes? Are they able to reach their feet to apply medication? What other medications are they taking? Are there any kidney or liver issues that are cause for concern?
Another question to consider is whether they have concurrent nail psoriasis. “When I have those patients, I often treat the onychomycosis first and the nail psoriasis second,” she said.
Evidence for Lasers Weak
Though laser therapy is FDA approved for the temporary increase of clear nails in onychomycosis, Vlahovic is underwhelmed by the evidence of its use for onychomycosis. According to a systematic review of 261 studies, only 1 reported treatment success as 16.7%, and clinical cures ranged from 13% to 16%. “Many of the existing studies were so poorly done in terms of protocols; it was frustrating,” she said. “No study has reported complete cure. There’s a lack of standardization across laser companies and a lack of standardization across protocols.”
Before starting oral antifungal therapy, Vlahovic uses the Onychomycosis Severity Index to determine the number of nails involved and the proportion of nails that are affected. She also wants to know if the patient is taking any medication that might interfere with an oral antifungal and gets baseline liver function tests (LFTs) to document results in the chart. “You want to discuss the pros and cons of oral antifungal therapy, and you want to set realistic expectations,” she added. “These medications are not cosmetic products; they are meant to kill fungus. Sometimes patients lose sight of that.”
Vlahovic routinely offers pulse dosing of terbinafine, which is FDA approved at a dose of 250 mg/d for 90 days. Pulse dosing involves taking terbinafine 250 mg twice a day for 1 week, followed by a 3-week break. This cycle is repeated three or four times. A clinical trial found no significant difference in outcome between patients who received pulsed vs continuous terbinafine dosing for the treatment of dermatophyte onychomycosis.
What About Oral Antifungal Safety?
For patients who ask about the safety of oral antifungals, Vlahovic characterized them as “well tolerated and safe in an immunocompetent population.” In a meta-analysis of 122 studies of about 22,000 patients, the pooled risk for treatment discontinuation because of adverse events was 3.4% for terbinafine 250 mg/d and 4.21% for itraconazole 200 mg/d. The risk for liver injury requiring termination of treatment and the risk of having symptomatic elevation of LFTs were less than 2% for all regimens.
According to the best available published evidence, Vlahovic said, the onychomycosis recurrence rate ranges from 6% to 40%. “That’s a wild number. We really have no idea what the true recurrence rate is, and that’s a problem.”
Vlahovic disclosed having been a consultant to and an investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
According to Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, most cases of onychomycosis are caused by the dermatophytes Trichophyton rubrum and T mentagrophytes, although the cause can also be a mixed infection. “Dermatophytes are going to impact the nails first, and molds may come in and join the party later,” she said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“The distal subungual onychomycosis (DSO) type is still the most common, but don’t forget that onychomycosis and nail psoriasis can happen at the same time. What we can’t lose sight of is that onychomycosis is a disease of the nail bed, which ultimately affects the nail plate; it’s not a disease of the nail plate first.”
Her diagnostic approach combines periodic acid-Schiff (PAS) staining with fungal culture “because I like to know the speciation,” she said. “PAS doesn’t give me the speciation; fungal cultures should. PCR can be expensive, but that can give me speciation.”
How Does This Happen?
Fungal DSO occurs because of exposure to a dermatophyte, which can be as simple as tinea pedis. “Perhaps it’s the environment in the shoe,” said Vlahovic, one of the authors of a textbook on onychomycosis. “That’s something I’m always concentrating on with the patient. What is your foot hygiene like? What’s your shoe and sock wear? What’s your level of physical activity? You can have trauma to the hyponychium, where the skin and the nail meet. Maybe they trim their nails too close to the skin, or maybe there’s another skin condition like psoriasis.”
The dermatophyte, she continued, enters and invades the nail at the hyponychium and uses the keratinase enzyme to digest keratin in the nail bed. Mild inflammation develops, and pH changes cause focal parakeratosis and subungual hyperkeratosis in the form of onycholysis and subungual debris. “Hyphae then invade the lamina of the nail plate, which causes brittle nails,” she said. “The compromised hyponychium creates a reservoir for molds and bacteria.”
Therapies approved by the Food and Drug Administration (FDA) for onychomycosis include the topical agents efinaconazole, tavaborole, and ciclopirox; the oral agents terbinafine and itraconazole; and laser therapy. Off-label, Vlahovic said that she sometimes uses oral fluconazole, pulsed dosing for terbinafine, and booster doses of terbinafine or any approved oral antifungal agent. Pulse dosing for itraconazole is FDA-approved for fingernails but not for toenails.
“We don’t have any oral antifungals that are approved for children, but we do have weight-based dosing,” she noted. Other off-label treatments for onychomycosis that patients may come across while browsing the internet but do not penetrate the nail plate, include products containing tolnaftate, tree oil, and undecylenic acid, “which is a very long-chain antifungal,” Vlahovic said. “It’s so huge that it can’t get through the nail plate. These products must get through the nail plate into the nail bed where the infection is.”
According to therapeutic recommendations for the treatment of toenail onychomycosis in the United States, published in 2021, terbinafine is the primary choice for oral treatment and efinaconazole 10% for topical treatment. There are no current treatment recommendations for pregnant or lactating patients. “I always defer to the obstetrician,” said Vlahovic, a coauthor of the recommendations. For pediatric patients, there are approved topical medications: Efinaconazole and tavaborole for ages 6 and up and ciclopirox for ages 12 years or older.
Treatment recommendations for adults vary based on clinical presentation and patient characteristics. Questions to consider: Are they older? Do they have diabetes? Are they able to reach their feet to apply medication? What other medications are they taking? Are there any kidney or liver issues that are cause for concern?
Another question to consider is whether they have concurrent nail psoriasis. “When I have those patients, I often treat the onychomycosis first and the nail psoriasis second,” she said.
Evidence for Lasers Weak
Though laser therapy is FDA approved for the temporary increase of clear nails in onychomycosis, Vlahovic is underwhelmed by the evidence of its use for onychomycosis. According to a systematic review of 261 studies, only 1 reported treatment success as 16.7%, and clinical cures ranged from 13% to 16%. “Many of the existing studies were so poorly done in terms of protocols; it was frustrating,” she said. “No study has reported complete cure. There’s a lack of standardization across laser companies and a lack of standardization across protocols.”
Before starting oral antifungal therapy, Vlahovic uses the Onychomycosis Severity Index to determine the number of nails involved and the proportion of nails that are affected. She also wants to know if the patient is taking any medication that might interfere with an oral antifungal and gets baseline liver function tests (LFTs) to document results in the chart. “You want to discuss the pros and cons of oral antifungal therapy, and you want to set realistic expectations,” she added. “These medications are not cosmetic products; they are meant to kill fungus. Sometimes patients lose sight of that.”
Vlahovic routinely offers pulse dosing of terbinafine, which is FDA approved at a dose of 250 mg/d for 90 days. Pulse dosing involves taking terbinafine 250 mg twice a day for 1 week, followed by a 3-week break. This cycle is repeated three or four times. A clinical trial found no significant difference in outcome between patients who received pulsed vs continuous terbinafine dosing for the treatment of dermatophyte onychomycosis.
What About Oral Antifungal Safety?
For patients who ask about the safety of oral antifungals, Vlahovic characterized them as “well tolerated and safe in an immunocompetent population.” In a meta-analysis of 122 studies of about 22,000 patients, the pooled risk for treatment discontinuation because of adverse events was 3.4% for terbinafine 250 mg/d and 4.21% for itraconazole 200 mg/d. The risk for liver injury requiring termination of treatment and the risk of having symptomatic elevation of LFTs were less than 2% for all regimens.
According to the best available published evidence, Vlahovic said, the onychomycosis recurrence rate ranges from 6% to 40%. “That’s a wild number. We really have no idea what the true recurrence rate is, and that’s a problem.”
Vlahovic disclosed having been a consultant to and an investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
FROM SDPA 2024
Study Finds Different Survival Rates for Hidradenitis Suppurativa Treatments in Children
results from a small single-center study showed.
A previous study found that overall drug survival of adalimumab and infliximab in adults with HS at 12 and 24 months was 56.3% and 30.5%, and 58.3% and 48.6%, respectively. “They also found that older age, longer disease duration, higher body mass index (BMI), and surgery during treatment are associated with increased drug survival,” Robyn Guo, a third-year medical student at Duke University, Durham, North Carolina, told this news organization following the annual Symposium on Hidradenitis Suppurativa Advances, where the study was presented during an oral abstract session. “To our knowledge, the drug survival of biologic therapies in pediatric HS patients has not been previously investigated.”
Adalimumab and infliximab are tumor necrosis factor blockers approved for multiple indications; adalimumab is approved for treating moderate to severe HS in patients aged 12 years or older. Infliximab is not approved for HS but is used to treat the disease.
To determine the drug survival of adalimumab and infliximab in pediatric patients with HS and whether patient comorbidities and HS lesion location are associated with length of biologic survival in pediatric patients with HS, Guo and colleagues used Kaplan-Meier survival curves to calculate biologic survival at 12 and 24 months following biologic initiation and Cox proportional hazards regression to analyze potential factors associated with biologic survival. The study population included 49 pediatric patients in the adalimumab cohort and 11 in the infliximab cohort.
The researchers found that drug survival for adalimumab was 90.6% at 12 months (95% CI, 83.0%-98.8%) and 78.3% at 24 months (95% CI, 67.7%-90.6%), while drug survival for infliximab was 54.5% at 12 months (95% CI, 31.8%-93.6%) and 36.4% at 24 months, an overall difference that reached statistical significance (P = .0009). “Our data suggests that adalimumab survival is significantly higher than infliximab survival in pediatric HS patients,” Guo said.
On univariate Cox regression analysis, gluteal HS lesions were associated with shorter adalimumab survival, and obesity was associated with longer infliximab survival.
The researchers acknowledged certain limitations of their study, including the small sample size and that unadjusted Cox regression analysis did not account for baseline HS severity, biologic therapy dosing, and concomitant medication use. Also, there were patients in both cohorts who were not biologic-naive: Two in the adalimumab cohort were previously treated with infliximab, and five patients in the infliximab cohort were previously treated with adalimumab.
“We plan on conducting further analysis using adjusted Cox regression analysis to account for baseline disease severity measured by Hurley stage, BMI, medication dosing, and concomitant medication use,” Guo said.
The researchers reported having no financial disclosures.
A version of this article appeared on Medscape.com.
results from a small single-center study showed.
A previous study found that overall drug survival of adalimumab and infliximab in adults with HS at 12 and 24 months was 56.3% and 30.5%, and 58.3% and 48.6%, respectively. “They also found that older age, longer disease duration, higher body mass index (BMI), and surgery during treatment are associated with increased drug survival,” Robyn Guo, a third-year medical student at Duke University, Durham, North Carolina, told this news organization following the annual Symposium on Hidradenitis Suppurativa Advances, where the study was presented during an oral abstract session. “To our knowledge, the drug survival of biologic therapies in pediatric HS patients has not been previously investigated.”
Adalimumab and infliximab are tumor necrosis factor blockers approved for multiple indications; adalimumab is approved for treating moderate to severe HS in patients aged 12 years or older. Infliximab is not approved for HS but is used to treat the disease.
To determine the drug survival of adalimumab and infliximab in pediatric patients with HS and whether patient comorbidities and HS lesion location are associated with length of biologic survival in pediatric patients with HS, Guo and colleagues used Kaplan-Meier survival curves to calculate biologic survival at 12 and 24 months following biologic initiation and Cox proportional hazards regression to analyze potential factors associated with biologic survival. The study population included 49 pediatric patients in the adalimumab cohort and 11 in the infliximab cohort.
The researchers found that drug survival for adalimumab was 90.6% at 12 months (95% CI, 83.0%-98.8%) and 78.3% at 24 months (95% CI, 67.7%-90.6%), while drug survival for infliximab was 54.5% at 12 months (95% CI, 31.8%-93.6%) and 36.4% at 24 months, an overall difference that reached statistical significance (P = .0009). “Our data suggests that adalimumab survival is significantly higher than infliximab survival in pediatric HS patients,” Guo said.
On univariate Cox regression analysis, gluteal HS lesions were associated with shorter adalimumab survival, and obesity was associated with longer infliximab survival.
The researchers acknowledged certain limitations of their study, including the small sample size and that unadjusted Cox regression analysis did not account for baseline HS severity, biologic therapy dosing, and concomitant medication use. Also, there were patients in both cohorts who were not biologic-naive: Two in the adalimumab cohort were previously treated with infliximab, and five patients in the infliximab cohort were previously treated with adalimumab.
“We plan on conducting further analysis using adjusted Cox regression analysis to account for baseline disease severity measured by Hurley stage, BMI, medication dosing, and concomitant medication use,” Guo said.
The researchers reported having no financial disclosures.
A version of this article appeared on Medscape.com.
results from a small single-center study showed.
A previous study found that overall drug survival of adalimumab and infliximab in adults with HS at 12 and 24 months was 56.3% and 30.5%, and 58.3% and 48.6%, respectively. “They also found that older age, longer disease duration, higher body mass index (BMI), and surgery during treatment are associated with increased drug survival,” Robyn Guo, a third-year medical student at Duke University, Durham, North Carolina, told this news organization following the annual Symposium on Hidradenitis Suppurativa Advances, where the study was presented during an oral abstract session. “To our knowledge, the drug survival of biologic therapies in pediatric HS patients has not been previously investigated.”
Adalimumab and infliximab are tumor necrosis factor blockers approved for multiple indications; adalimumab is approved for treating moderate to severe HS in patients aged 12 years or older. Infliximab is not approved for HS but is used to treat the disease.
To determine the drug survival of adalimumab and infliximab in pediatric patients with HS and whether patient comorbidities and HS lesion location are associated with length of biologic survival in pediatric patients with HS, Guo and colleagues used Kaplan-Meier survival curves to calculate biologic survival at 12 and 24 months following biologic initiation and Cox proportional hazards regression to analyze potential factors associated with biologic survival. The study population included 49 pediatric patients in the adalimumab cohort and 11 in the infliximab cohort.
The researchers found that drug survival for adalimumab was 90.6% at 12 months (95% CI, 83.0%-98.8%) and 78.3% at 24 months (95% CI, 67.7%-90.6%), while drug survival for infliximab was 54.5% at 12 months (95% CI, 31.8%-93.6%) and 36.4% at 24 months, an overall difference that reached statistical significance (P = .0009). “Our data suggests that adalimumab survival is significantly higher than infliximab survival in pediatric HS patients,” Guo said.
On univariate Cox regression analysis, gluteal HS lesions were associated with shorter adalimumab survival, and obesity was associated with longer infliximab survival.
The researchers acknowledged certain limitations of their study, including the small sample size and that unadjusted Cox regression analysis did not account for baseline HS severity, biologic therapy dosing, and concomitant medication use. Also, there were patients in both cohorts who were not biologic-naive: Two in the adalimumab cohort were previously treated with infliximab, and five patients in the infliximab cohort were previously treated with adalimumab.
“We plan on conducting further analysis using adjusted Cox regression analysis to account for baseline disease severity measured by Hurley stage, BMI, medication dosing, and concomitant medication use,” Guo said.
The researchers reported having no financial disclosures.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Managing Rosacea: Tips for Reducing Facial Erythema, Flushing
LAS VEGAS —
These agents “work fast” and “improve redness quickly,” Harper, a dermatologist who practices in Birmingham, Alabama, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. In addition, “you’re going to know within 30 minutes or an hour whether it’s going to work or not.”
Brimonidine 0.33% gel, an alpha-2 adrenergic receptor agonist, was approved by the Food and Drug Administration (FDA) in 2014 for persistent facial erythema of rosacea. It does not treat telangiectasia and is not approved for flushing (transient erythema). Patients are advised to apply the gel daily in the morning. In phase 3 pivotal trials of patients with moderate to severe erythema of rosacea, which excluded individuals with more than two papules, a composite (investigator- and patient-reported) 2-grade improvement was seen as early as 30 minutes after application on day 1, and erythema was reduced for 9-12 hours.
Oxymetazoline 1% cream, an alpha-1a adrenergic receptor agonist, was approved by the FDA in 2017 for persistent facial erythema of rosacea. It neither treats telangiectasia nor is approved for flushing. Phase 3 trials of patients with moderate to severe persistent erythema of rosacea excluded individuals with more than three inflammatory papules or pustules. A composite (investigator- and subject-reported) 2-grade improvement was seen as early as 1 hour after application on day 1, and erythema was reduced for 9-12 hours.
Receptor Selectivity Differences
According to Harper, there are more reports of worsening erythema with brimonidine 0.33% gel than with oxymetazoline 1% cream, perhaps because of the different receptor selectivity between the two products. She explained that alpha-1 receptors are located only postsynaptically in vascular smooth muscle, while alpha-2 receptors are located presynaptically, which can inhibit norepinephrine and lead to vasodilation. Alpha-2 receptors are also located postsynaptically in vascular smooth muscle and in the endothelial wall, which can mediate nitric oxide release and cause vasodilation.
No head-to-head studies exist that compare brimonidine 0.33% gel with oxymetazoline 1% cream. But in a 52-week study of oxymetazoline 1% cream for persistent facial erythema associated with rosacea published in 2018, at week 52, 36.7% and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Also, fewer than 1% of patients experienced a rebound effect following treatment cessation.
“What we learned from this study is that maybe patients do better if they use oxymetazoline 1% cream consistently,” Harper said. “Does that mean that everybody I give this to uses it daily? Probably not, but I think we can change the vascular tone by using it consistently every day.”
Oral Beta-Blockers Another Option
Alpha agonists can also help quell flushing associated with rosacea, Harper continued, but oral beta-blockers may be the better choice. In a 2020 review that drew from nine studies, researchers evaluated the use of carvedilol, propranolol, nadolol, and beta-blockers in general for rosacea-associated facial erythema and flushing. Articles studying carvedilol and propranolol showed a large reduction of erythema and flushing during treatment with a rapid onset of symptom control, while bradycardia and hypotension were the most commonly reported adverse events. “All of these agents are studied in rosacea, but none of them are FDA approved for rosacea,” Harper noted.
In a separate study, five patients with rosacea who had either severe frequent flushing episodes or persistent erythema and burning sensations were treated with carvedilol, a nonselective beta-blocker. Prior treatments included cetirizine and doxycycline, or isotretinoin combined with topical application of metronidazole gel or ivermectin without sufficient improvement in erythema. Carvedilol was added to the above treatments and titrated up to 12.5 mg twice a day and continued for at least 6 months.
The Clinician Erythema Assessment 5-point scale before therapy was 3.4 and dropped to 0.4 during therapy, while the patient self-assessment before therapy was 3.8 and dropped to 0.8 during therapy.
Another study evaluated the use of propranolol and/or doxycycline in 78 patients with rosacea. The propranolol and combination treatment groups showed more rapid improvement at weeks 4 and 8, but there was no statistically significant difference between them by week 12. Rosacea clinical scores also decreased in all groups, but there were no significant differences between them. Reduction of Assessment of Rosacea Clinical Score was 51%, 52.2%, and 57.3% in the propranolol, doxycycline, and combination groups, respectively.
Harper disclosed ties with Almirall, Cutera, Galderma, Journey, Ortho Dermatologics, and Sun Pharmaceutical Industries.
A version of this article appeared on Medscape.com.
LAS VEGAS —
These agents “work fast” and “improve redness quickly,” Harper, a dermatologist who practices in Birmingham, Alabama, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. In addition, “you’re going to know within 30 minutes or an hour whether it’s going to work or not.”
Brimonidine 0.33% gel, an alpha-2 adrenergic receptor agonist, was approved by the Food and Drug Administration (FDA) in 2014 for persistent facial erythema of rosacea. It does not treat telangiectasia and is not approved for flushing (transient erythema). Patients are advised to apply the gel daily in the morning. In phase 3 pivotal trials of patients with moderate to severe erythema of rosacea, which excluded individuals with more than two papules, a composite (investigator- and patient-reported) 2-grade improvement was seen as early as 30 minutes after application on day 1, and erythema was reduced for 9-12 hours.
Oxymetazoline 1% cream, an alpha-1a adrenergic receptor agonist, was approved by the FDA in 2017 for persistent facial erythema of rosacea. It neither treats telangiectasia nor is approved for flushing. Phase 3 trials of patients with moderate to severe persistent erythema of rosacea excluded individuals with more than three inflammatory papules or pustules. A composite (investigator- and subject-reported) 2-grade improvement was seen as early as 1 hour after application on day 1, and erythema was reduced for 9-12 hours.
Receptor Selectivity Differences
According to Harper, there are more reports of worsening erythema with brimonidine 0.33% gel than with oxymetazoline 1% cream, perhaps because of the different receptor selectivity between the two products. She explained that alpha-1 receptors are located only postsynaptically in vascular smooth muscle, while alpha-2 receptors are located presynaptically, which can inhibit norepinephrine and lead to vasodilation. Alpha-2 receptors are also located postsynaptically in vascular smooth muscle and in the endothelial wall, which can mediate nitric oxide release and cause vasodilation.
No head-to-head studies exist that compare brimonidine 0.33% gel with oxymetazoline 1% cream. But in a 52-week study of oxymetazoline 1% cream for persistent facial erythema associated with rosacea published in 2018, at week 52, 36.7% and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Also, fewer than 1% of patients experienced a rebound effect following treatment cessation.
“What we learned from this study is that maybe patients do better if they use oxymetazoline 1% cream consistently,” Harper said. “Does that mean that everybody I give this to uses it daily? Probably not, but I think we can change the vascular tone by using it consistently every day.”
Oral Beta-Blockers Another Option
Alpha agonists can also help quell flushing associated with rosacea, Harper continued, but oral beta-blockers may be the better choice. In a 2020 review that drew from nine studies, researchers evaluated the use of carvedilol, propranolol, nadolol, and beta-blockers in general for rosacea-associated facial erythema and flushing. Articles studying carvedilol and propranolol showed a large reduction of erythema and flushing during treatment with a rapid onset of symptom control, while bradycardia and hypotension were the most commonly reported adverse events. “All of these agents are studied in rosacea, but none of them are FDA approved for rosacea,” Harper noted.
In a separate study, five patients with rosacea who had either severe frequent flushing episodes or persistent erythema and burning sensations were treated with carvedilol, a nonselective beta-blocker. Prior treatments included cetirizine and doxycycline, or isotretinoin combined with topical application of metronidazole gel or ivermectin without sufficient improvement in erythema. Carvedilol was added to the above treatments and titrated up to 12.5 mg twice a day and continued for at least 6 months.
The Clinician Erythema Assessment 5-point scale before therapy was 3.4 and dropped to 0.4 during therapy, while the patient self-assessment before therapy was 3.8 and dropped to 0.8 during therapy.
Another study evaluated the use of propranolol and/or doxycycline in 78 patients with rosacea. The propranolol and combination treatment groups showed more rapid improvement at weeks 4 and 8, but there was no statistically significant difference between them by week 12. Rosacea clinical scores also decreased in all groups, but there were no significant differences between them. Reduction of Assessment of Rosacea Clinical Score was 51%, 52.2%, and 57.3% in the propranolol, doxycycline, and combination groups, respectively.
Harper disclosed ties with Almirall, Cutera, Galderma, Journey, Ortho Dermatologics, and Sun Pharmaceutical Industries.
A version of this article appeared on Medscape.com.
LAS VEGAS —
These agents “work fast” and “improve redness quickly,” Harper, a dermatologist who practices in Birmingham, Alabama, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. In addition, “you’re going to know within 30 minutes or an hour whether it’s going to work or not.”
Brimonidine 0.33% gel, an alpha-2 adrenergic receptor agonist, was approved by the Food and Drug Administration (FDA) in 2014 for persistent facial erythema of rosacea. It does not treat telangiectasia and is not approved for flushing (transient erythema). Patients are advised to apply the gel daily in the morning. In phase 3 pivotal trials of patients with moderate to severe erythema of rosacea, which excluded individuals with more than two papules, a composite (investigator- and patient-reported) 2-grade improvement was seen as early as 30 minutes after application on day 1, and erythema was reduced for 9-12 hours.
Oxymetazoline 1% cream, an alpha-1a adrenergic receptor agonist, was approved by the FDA in 2017 for persistent facial erythema of rosacea. It neither treats telangiectasia nor is approved for flushing. Phase 3 trials of patients with moderate to severe persistent erythema of rosacea excluded individuals with more than three inflammatory papules or pustules. A composite (investigator- and subject-reported) 2-grade improvement was seen as early as 1 hour after application on day 1, and erythema was reduced for 9-12 hours.
Receptor Selectivity Differences
According to Harper, there are more reports of worsening erythema with brimonidine 0.33% gel than with oxymetazoline 1% cream, perhaps because of the different receptor selectivity between the two products. She explained that alpha-1 receptors are located only postsynaptically in vascular smooth muscle, while alpha-2 receptors are located presynaptically, which can inhibit norepinephrine and lead to vasodilation. Alpha-2 receptors are also located postsynaptically in vascular smooth muscle and in the endothelial wall, which can mediate nitric oxide release and cause vasodilation.
No head-to-head studies exist that compare brimonidine 0.33% gel with oxymetazoline 1% cream. But in a 52-week study of oxymetazoline 1% cream for persistent facial erythema associated with rosacea published in 2018, at week 52, 36.7% and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Also, fewer than 1% of patients experienced a rebound effect following treatment cessation.
“What we learned from this study is that maybe patients do better if they use oxymetazoline 1% cream consistently,” Harper said. “Does that mean that everybody I give this to uses it daily? Probably not, but I think we can change the vascular tone by using it consistently every day.”
Oral Beta-Blockers Another Option
Alpha agonists can also help quell flushing associated with rosacea, Harper continued, but oral beta-blockers may be the better choice. In a 2020 review that drew from nine studies, researchers evaluated the use of carvedilol, propranolol, nadolol, and beta-blockers in general for rosacea-associated facial erythema and flushing. Articles studying carvedilol and propranolol showed a large reduction of erythema and flushing during treatment with a rapid onset of symptom control, while bradycardia and hypotension were the most commonly reported adverse events. “All of these agents are studied in rosacea, but none of them are FDA approved for rosacea,” Harper noted.
In a separate study, five patients with rosacea who had either severe frequent flushing episodes or persistent erythema and burning sensations were treated with carvedilol, a nonselective beta-blocker. Prior treatments included cetirizine and doxycycline, or isotretinoin combined with topical application of metronidazole gel or ivermectin without sufficient improvement in erythema. Carvedilol was added to the above treatments and titrated up to 12.5 mg twice a day and continued for at least 6 months.
The Clinician Erythema Assessment 5-point scale before therapy was 3.4 and dropped to 0.4 during therapy, while the patient self-assessment before therapy was 3.8 and dropped to 0.8 during therapy.
Another study evaluated the use of propranolol and/or doxycycline in 78 patients with rosacea. The propranolol and combination treatment groups showed more rapid improvement at weeks 4 and 8, but there was no statistically significant difference between them by week 12. Rosacea clinical scores also decreased in all groups, but there were no significant differences between them. Reduction of Assessment of Rosacea Clinical Score was 51%, 52.2%, and 57.3% in the propranolol, doxycycline, and combination groups, respectively.
Harper disclosed ties with Almirall, Cutera, Galderma, Journey, Ortho Dermatologics, and Sun Pharmaceutical Industries.
A version of this article appeared on Medscape.com.
FROM SDPA 2024
FDA Approves Bimekizumab For Treating Hidradenitis Suppurativa
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Approval was based on results from two phase 3 studies, BE HEARD I and BE HEARD II, which found that bimekizumab improved the signs and symptoms of disease compared with placebo at week 16 and were sustained to week 48, according to a press release from UCB, the drug’s manufacturer. In both trials, a higher proportion of patients treated with bimekizumab achieved Hidradenitis Suppurativa Clinical Response (HiSCR) scores of 50 and 75 compared with those who received placebo.
The company noted that bimekizumab (Bimzelx) is the first and only approved medicine designed to selectively inhibit IL-17F in addition to IL-17A. According to the prescribing information, the recommended dosing for patients with HS is 320 mg administered by subcutaneous injection at week 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
“The approval of bimekizumab for moderate-to-severe HS is tremendous news for people living with HS” and the clinicians who care for them, Jennifer L. Hsiao, MD, director of the HS clinic at the University of Southern California, Los Angeles, told this news organization.
“It is exciting that we already have two-year trial data for bimekizumab in HS and can see that bimekizumab raises the bar in terms of depth and durability of response that we can expect to see in our patients,” she added. “Given the limited treatment options for HS at this time, the addition of bimekizumab to our treatment armamentarium is a huge step forward for the HS community.”
This development marks the fifth approved indication for bimekizumab since it was first approved in October 2023 for the treatment of moderate to severe plaque psoriasis, followed by approvals for active psoriatic arthritis, nonradiographic axial spondyloarthritis, and active ankylosing spondylitis in September 2024.
According to the prescribing information, certain adverse reactions have been observed with bimekizumab, including suicidal ideation and behavior, infections, liver biochemical abnormalities, and inflammatory bowel disease. A pregnancy exposure registry has been established that monitors pregnancy outcomes in women exposed to bimekizumab. For information, clinicians or patients can contact the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study at 1-877-311- 8972 or visit MotherToBaby Pregnancy Studies.
Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, Sanofi, and UCB; a speaker for AbbVie, Galderma, Novartis, Sanofi Regeneron, and UCB; and an investigator for Amgen, Boehringer Ingelheim, and Incyte.
A version of this article first appeared on Medscape.com.
.
Approval was based on results from two phase 3 studies, BE HEARD I and BE HEARD II, which found that bimekizumab improved the signs and symptoms of disease compared with placebo at week 16 and were sustained to week 48, according to a press release from UCB, the drug’s manufacturer. In both trials, a higher proportion of patients treated with bimekizumab achieved Hidradenitis Suppurativa Clinical Response (HiSCR) scores of 50 and 75 compared with those who received placebo.
The company noted that bimekizumab (Bimzelx) is the first and only approved medicine designed to selectively inhibit IL-17F in addition to IL-17A. According to the prescribing information, the recommended dosing for patients with HS is 320 mg administered by subcutaneous injection at week 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
“The approval of bimekizumab for moderate-to-severe HS is tremendous news for people living with HS” and the clinicians who care for them, Jennifer L. Hsiao, MD, director of the HS clinic at the University of Southern California, Los Angeles, told this news organization.
“It is exciting that we already have two-year trial data for bimekizumab in HS and can see that bimekizumab raises the bar in terms of depth and durability of response that we can expect to see in our patients,” she added. “Given the limited treatment options for HS at this time, the addition of bimekizumab to our treatment armamentarium is a huge step forward for the HS community.”
This development marks the fifth approved indication for bimekizumab since it was first approved in October 2023 for the treatment of moderate to severe plaque psoriasis, followed by approvals for active psoriatic arthritis, nonradiographic axial spondyloarthritis, and active ankylosing spondylitis in September 2024.
According to the prescribing information, certain adverse reactions have been observed with bimekizumab, including suicidal ideation and behavior, infections, liver biochemical abnormalities, and inflammatory bowel disease. A pregnancy exposure registry has been established that monitors pregnancy outcomes in women exposed to bimekizumab. For information, clinicians or patients can contact the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study at 1-877-311- 8972 or visit MotherToBaby Pregnancy Studies.
Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, Sanofi, and UCB; a speaker for AbbVie, Galderma, Novartis, Sanofi Regeneron, and UCB; and an investigator for Amgen, Boehringer Ingelheim, and Incyte.
A version of this article first appeared on Medscape.com.
.
Approval was based on results from two phase 3 studies, BE HEARD I and BE HEARD II, which found that bimekizumab improved the signs and symptoms of disease compared with placebo at week 16 and were sustained to week 48, according to a press release from UCB, the drug’s manufacturer. In both trials, a higher proportion of patients treated with bimekizumab achieved Hidradenitis Suppurativa Clinical Response (HiSCR) scores of 50 and 75 compared with those who received placebo.
The company noted that bimekizumab (Bimzelx) is the first and only approved medicine designed to selectively inhibit IL-17F in addition to IL-17A. According to the prescribing information, the recommended dosing for patients with HS is 320 mg administered by subcutaneous injection at week 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
“The approval of bimekizumab for moderate-to-severe HS is tremendous news for people living with HS” and the clinicians who care for them, Jennifer L. Hsiao, MD, director of the HS clinic at the University of Southern California, Los Angeles, told this news organization.
“It is exciting that we already have two-year trial data for bimekizumab in HS and can see that bimekizumab raises the bar in terms of depth and durability of response that we can expect to see in our patients,” she added. “Given the limited treatment options for HS at this time, the addition of bimekizumab to our treatment armamentarium is a huge step forward for the HS community.”
This development marks the fifth approved indication for bimekizumab since it was first approved in October 2023 for the treatment of moderate to severe plaque psoriasis, followed by approvals for active psoriatic arthritis, nonradiographic axial spondyloarthritis, and active ankylosing spondylitis in September 2024.
According to the prescribing information, certain adverse reactions have been observed with bimekizumab, including suicidal ideation and behavior, infections, liver biochemical abnormalities, and inflammatory bowel disease. A pregnancy exposure registry has been established that monitors pregnancy outcomes in women exposed to bimekizumab. For information, clinicians or patients can contact the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases Study at 1-877-311- 8972 or visit MotherToBaby Pregnancy Studies.
Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, Sanofi, and UCB; a speaker for AbbVie, Galderma, Novartis, Sanofi Regeneron, and UCB; and an investigator for Amgen, Boehringer Ingelheim, and Incyte.
A version of this article first appeared on Medscape.com.
Tips on Handling a Negative Patient Review
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Expert Reviews Options for Revitalizing Dystrophic Nails
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Topical Retinoids a Key Component of Acne Treatment Regimens
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM SDPA 2024