Acne

TOPLINE:

The efficacy of clascoterone cream 1% for treating acne vulgaris appears to increase over time after 12 weeks of use and up to 1 year.

METHODOLOGY:

• A 1% cream formulation of clascoterone, a topical androgen receptor inhibitor, is approved for the treatment of acne vulgaris in patients aged 12 years and older based on results from two identical phase 3 12-week trials, NCT02608450 and NCT02608476, and a long-term extension (LTE) study.
• The purpose of the current study was to evaluate the integrated efficacy of clascoterone cream 1% (Winlevi) in the intention-to-treat population of patients from all three trials.
• In the pivotal trials, investigators randomized patients with acne 1:1 to receive clascoterone cream 1% or vehicle twice daily for 12 weeks. Participants were eligible to enter the LTE study, in which patients applied clascoterone to the face, and if they wanted to, the trunk for up to 9 more months.
• To assess combined efficacy, researchers evaluated the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of 0 or 1.

TAKEAWAY:

• Of the 1143 patients from the pivotal trials who completed 12 weeks of treatment, 576 were in the clascoterone group and 567 were in the vehicle group. Of the 600 patients who entered the LTE study, 311 were in the clascoterone group and 289 were in the vehicle group. Of these, 343 completed the LTE study.
• At week 12, the proportion of patients who achieved treatment success was higher in the clascoterone group than in the vehicle group (19.9% vs 7.7%, respectively; P < .0001).
• In the LTE study, the proportion of patients previously treated with clascoterone who achieved a facial IGA of 0/1 increased from 13.5% at extension day 0 to 29.9% at extension day 274, while the proportion of patients previously treated with vehicle and switched to clascoterone who achieved a facial IGA of 0/1 increased from 6.2% at extension day 0 to 30.4% at extension day 274.
• Similarly, the proportion of patients in the LTE study with a truncal IGA of 0/1 increased from 4.9% at extension day 0 to 31.7% on extension day 274.

IN PRACTICE:

“Clinicians may consider counseling patients that treatment persistence is required to maximize the efficacy of clascoterone treatment,” the authors concluded.

SOURCE:

Lawrence F. Eichenfield, MD, of the departments of dermatology and pediatrics at the University of California and Rady Children’s Hospital, San Diego, California, led the research. The study was published in the January 2024 issue of the Journal of Drugs in Dermatology.

LIMITATIONS:

There was a high patient discontinuation rate before and during the LET study. Also, no assessment was made as to how clascoterone affected patients’ quality of life.

DISCLOSURES:

Clascoterone manufacturer Cassiopea funded the studies. Dr. Eichenfield and fellow investigators Adelaide A. Hebert, MD, and Linda Stein Gold, MD, received compensation from Cassiopea as advisers and disclosed ties to many other pharmaceutical companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The efficacy of clascoterone cream 1% for treating acne vulgaris appears to increase over time after 12 weeks of use and up to 1 year.

METHODOLOGY:

• A 1% cream formulation of clascoterone, a topical androgen receptor inhibitor, is approved for the treatment of acne vulgaris in patients aged 12 years and older based on results from two identical phase 3 12-week trials, NCT02608450 and NCT02608476, and a long-term extension (LTE) study.
• The purpose of the current study was to evaluate the integrated efficacy of clascoterone cream 1% (Winlevi) in the intention-to-treat population of patients from all three trials.
• In the pivotal trials, investigators randomized patients with acne 1:1 to receive clascoterone cream 1% or vehicle twice daily for 12 weeks. Participants were eligible to enter the LTE study, in which patients applied clascoterone to the face, and if they wanted to, the trunk for up to 9 more months.
• To assess combined efficacy, researchers evaluated the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of 0 or 1.

TAKEAWAY:

• Of the 1143 patients from the pivotal trials who completed 12 weeks of treatment, 576 were in the clascoterone group and 567 were in the vehicle group. Of the 600 patients who entered the LTE study, 311 were in the clascoterone group and 289 were in the vehicle group. Of these, 343 completed the LTE study.
• At week 12, the proportion of patients who achieved treatment success was higher in the clascoterone group than in the vehicle group (19.9% vs 7.7%, respectively; P < .0001).
• In the LTE study, the proportion of patients previously treated with clascoterone who achieved a facial IGA of 0/1 increased from 13.5% at extension day 0 to 29.9% at extension day 274, while the proportion of patients previously treated with vehicle and switched to clascoterone who achieved a facial IGA of 0/1 increased from 6.2% at extension day 0 to 30.4% at extension day 274.
• Similarly, the proportion of patients in the LTE study with a truncal IGA of 0/1 increased from 4.9% at extension day 0 to 31.7% on extension day 274.

IN PRACTICE:

“Clinicians may consider counseling patients that treatment persistence is required to maximize the efficacy of clascoterone treatment,” the authors concluded.

SOURCE:

Lawrence F. Eichenfield, MD, of the departments of dermatology and pediatrics at the University of California and Rady Children’s Hospital, San Diego, California, led the research. The study was published in the January 2024 issue of the Journal of Drugs in Dermatology.

LIMITATIONS:

There was a high patient discontinuation rate before and during the LET study. Also, no assessment was made as to how clascoterone affected patients’ quality of life.

DISCLOSURES:

Clascoterone manufacturer Cassiopea funded the studies. Dr. Eichenfield and fellow investigators Adelaide A. Hebert, MD, and Linda Stein Gold, MD, received compensation from Cassiopea as advisers and disclosed ties to many other pharmaceutical companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The efficacy of clascoterone cream 1% for treating acne vulgaris appears to increase over time after 12 weeks of use and up to 1 year.

METHODOLOGY:

• A 1% cream formulation of clascoterone, a topical androgen receptor inhibitor, is approved for the treatment of acne vulgaris in patients aged 12 years and older based on results from two identical phase 3 12-week trials, NCT02608450 and NCT02608476, and a long-term extension (LTE) study.
• The purpose of the current study was to evaluate the integrated efficacy of clascoterone cream 1% (Winlevi) in the intention-to-treat population of patients from all three trials.
• In the pivotal trials, investigators randomized patients with acne 1:1 to receive clascoterone cream 1% or vehicle twice daily for 12 weeks. Participants were eligible to enter the LTE study, in which patients applied clascoterone to the face, and if they wanted to, the trunk for up to 9 more months.
• To assess combined efficacy, researchers evaluated the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of 0 or 1.

TAKEAWAY:

• Of the 1143 patients from the pivotal trials who completed 12 weeks of treatment, 576 were in the clascoterone group and 567 were in the vehicle group. Of the 600 patients who entered the LTE study, 311 were in the clascoterone group and 289 were in the vehicle group. Of these, 343 completed the LTE study.
• At week 12, the proportion of patients who achieved treatment success was higher in the clascoterone group than in the vehicle group (19.9% vs 7.7%, respectively; P < .0001).
• In the LTE study, the proportion of patients previously treated with clascoterone who achieved a facial IGA of 0/1 increased from 13.5% at extension day 0 to 29.9% at extension day 274, while the proportion of patients previously treated with vehicle and switched to clascoterone who achieved a facial IGA of 0/1 increased from 6.2% at extension day 0 to 30.4% at extension day 274.
• Similarly, the proportion of patients in the LTE study with a truncal IGA of 0/1 increased from 4.9% at extension day 0 to 31.7% on extension day 274.

IN PRACTICE:

“Clinicians may consider counseling patients that treatment persistence is required to maximize the efficacy of clascoterone treatment,” the authors concluded.

SOURCE:

Lawrence F. Eichenfield, MD, of the departments of dermatology and pediatrics at the University of California and Rady Children’s Hospital, San Diego, California, led the research. The study was published in the January 2024 issue of the Journal of Drugs in Dermatology.

LIMITATIONS:

There was a high patient discontinuation rate before and during the LET study. Also, no assessment was made as to how clascoterone affected patients’ quality of life.

DISCLOSURES:

Clascoterone manufacturer Cassiopea funded the studies. Dr. Eichenfield and fellow investigators Adelaide A. Hebert, MD, and Linda Stein Gold, MD, received compensation from Cassiopea as advisers and disclosed ties to many other pharmaceutical companies.
 

A version of this article appeared on Medscape.com.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

Myo-inositol promotes the entry of glucose into the cell and is a safe and often effective supplement to recommend for acne, particularly for those patients who do not want traditional treatments, such as antibiotics, spironolactone, or isotretinoin, Jonette Elizabeth Keri, MD, PhD, professor of dermatology at the University of Miami, said during a presentation on therapies for acne at the annual Integrative Dermatology Symposium.

Probiotics and omega-3 fatty acids are among the other complementary therapies that have a role in acne treatment, she and others said during the meeting.

Anna Gawlik/iStock/Getty Images

Myo-inositol has been well-studied in the gynecology-endocrinology community in patients with polycystic ovary syndrome (PCOS), demonstrating an ability to improve the metabolic profile and reduce acne and hirsutism, Dr. Keri said.

A study of 137 young, overweight women with PCOS and moderate acne, for example, found that compared with placebo, 6 months of myo-inositol or D-chiro-inositol, another isoform of inositol, significantly improved the acne score, endocrine and metabolic parameters, insulin resistance, and regularity of the menstrual cycle, Dr. Keri said. Both isoforms of inositol are second messengers in the signal transduction of insulin.

During a panel discussion, asked about a case of an adult female with acne, Dr. Keri said that many of her adult female patients “don’t want to do isotretinoin or antibiotics, and they don’t want to do any kind of hormonal treatment,” the options she would recommend. But for patients who do not want these treatments, she said, “I go down the route of supplements,” and myo-inositol is her “favorite” option. It’s safe to use during pregnancy, she emphasized, noting that myo-inositol is being studied for the prevention of preterm birth.

Dr. Keri, who described herself as “more of a traditionalist,” prescribes myo-inositol 2 gm twice a day in pill form. In Europe, she noted in her presentation, myo-inositol is also compounded for topical use.
 

Diet, probiotics, other nutraceuticals

A low-glycemic-load diet was among several complementary therapies reported in a 2015 Cochrane Database Systematic Review to have some evidence (though low-quality) of reducing total skin lesions in acne (along with tea tree oil and bee venom) and today, it is the most evidence-based dietary recommendation for acne, Dr. Keri said.

Mensent Photography/Moment/Getty Images

Omega-3 fatty acids and increased fruit and vegetable intake have also been reported to be acne-protective — and hyperglycemia, carbohydrates, milk and dairy products, and saturated fats and trans fats have been reported to be acne-promoting, she noted.

But, the low-glycemic-load data “is the strongest,” she said. The best advice for patients, she added, is to consume less sugar and fewer sugary drinks and “avoid white foods” such as white bread, rice, and pasta.

Probiotics can also be recommended, especially for patients on antibiotic therapy, Dr. Keri said. For “basic science evidence,” she pointed to a randomized, double-blinded, placebo-controlled study of 20 adults with acne, which evaluated the impact of a probiotic on improvement in acne and skin expression of genes involved with insulin signaling. Participants took either a liquid supplement containing Lactobacillus rhamnosus SP1 (LSP1) or placebo over a 12-week period. The investigators performed paired skin biopsies before and after 12 weeks of treatment and analyzed them for insulin-like growth factor 1 (IGF1) and forkhead box protein O1 (FOXO1) gene expression.

They found that compared with baseline, the probiotic group showed a 32% reduction in IGF1 and a 65% increase in FOXO1 gene expression (P < .0001 for both), with no such differences observed in the placebo group.

Clinically, patients in the probiotic group had an adjusted odds ratio of 28.4 (95% confidence interval, 2.2-411.1, P < .05) of acne being rated as improved or markedly improved compared with those on placebo.

Dr. Keri

Dr. Keri and others at the meeting also referenced a 2013 prospective, open-label trial that randomized 45 women with acne, ages 18-35 years, to one of three arms: Probiotic supplementation only, minocycline only, and both probiotic and minocycline. The probiotic used was a product containing Lactobacillus acidophilus, Lactobacillus bulgaricus, and Bifidobacterium bifidum. At 8 and 12 weeks, the combination group “did the best with the lowest total lesion count” compared with the probiotic group and the minocycline group, differences that were significant (P < .001 and P <.01, respectively), she said. “And they also had less candidiasis when using a probiotic than when using an antibiotic alone,” she said. Two patients in the minocycline-only group failed to complete the study because they developed vaginal candidiasis.

In addition to reducing potential adverse events secondary to chronic antibiotic use, probiotics can have synergistic anti-inflammatory effects, she said.

Dr. Keri said she recommends probiotics for patients taking antibiotics and encourages them “to get a branded probiotic,” such as Culturelle, “or if they prefer a food source, soy or almond milk–based yogurt.” As with other elements of a holistic approach to acne, she urged clinicians to consider the cost of treatment.

Probiotics (Lactobacillus plantarum) were one of four nutraceuticals determined in a 2023 systematic review to have “good-quality” evidence for potential efficacy, Dr. Keri noted, along with vitamin D, green tea extract, and cheongsangbangpoong-tang, the latter of which is an herbal therapeutic formula approved by the Korean Food and Drug Administration for use in acne.

“There were really no bad systemic effects for any of these,” she said. “The tricky part of this review is that each of the four have only one study” deemed to be a good-quality study. Omega-3 fatty acids were among several other nutraceuticals deemed to have “fair-quality” evidence for efficacy. Zinc was reported to be the most studied nutraceutical in acne, but didn’t rate as highly in the review. Dr. Keri said she likes to include zinc in her armamentarium because “it can be used in pregnant women,” noting that reviews and guidelines “are just that, a guide ... to combine with experience.”
 

Omega-3 fatty acids with isotretinoin

Several speakers at the meeting, including Steven Daveluy, MD, associate professor and residency program director in the department of dermatology, Wayne State University, Dearborn, Michigan, spoke about the value of omega-3 fatty acids in reducing side effects of isotretinoin. “In the FDA trials [of isotretinoin] they had patients take 50 grams of fat,” he said. “You can use the good fats to help you out.”

Research has shown that 1 gm per day of oral omega-3 reduces dryness of the lips, nose, eyes, and skin, “which are the big side effects we see with isotretinoin,” he said. An impact on triglyceride levels has also been demonstrated, Dr. Daveluy said, pointing to a longitudinal survey study of 39 patients treated with isotretinoin that showed a mean increase in triglyceride levels of 49% during treatment in patients who did not use omega-3 supplementation, compared with a mean increase of 13.9% (P =.04) in patients who used the supplements.“There is also evidence that omega-3 can decrease depression, which may or may not be a side effect of isotretinoin ... but it’s something we consider in our [acne] patients,” Dr. Daveluy said.

During a panel discussion at the meeting, Apple A. Bodemer, MD, associate professor of dermatology at the University of Wisconsin, Madison, said she usually prescribes 2 g of docosahexaenoic acid eicosapentaenoic acid combined in patients on isotretinoin because “at that dose, omega-3s have been found to be anti-inflammatory.”

Dr. Keri reported being an investigator and speaker for Galderma, and an advisory board member for Ortho Dermatologics and for Almirall. Dr. Daveluy reported no relevant disclosures.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of the US Food and Drug Administration (FDA) approvals for dermatologic drugs between 2012 and 2022 were considered first in class or first in indication.

METHODOLOGY:

• Only five new drugs for diseases treated mostly by dermatologists were approved by the FDA between 1999 and 2009.
• In a cross-sectional analysis to characterize the frequency and degree of innovation of dermatologic drugs approved more recently, researchers identified new and supplemental dermatologic drugs approved between January 1, 2012, and December 31, 2022, from FDA lists, Centers for Medicare & Medicaid Services CenterWatch, and peer-reviewed articles.
• They used five proxy measures to estimate each drug’s degree of innovation: FDA designation (first in class, advance in class, or addition to class), independent clinical usefulness ratings, and benefit ratings by health technology assessment organizations.

TAKEAWAY:

• The study authors identified 52 new drug applications and 26 supplemental new indications approved by the FDA for dermatologic indications between 2012 and 2022.
• Of the 52 new drugs, the researchers categorized 11 (21%) as first in class and 13 (25%) as first in indication.
• An analysis of benefit ratings available for 38 of the drugs showed that 15 (39%) were rated as being clinically useful or having high added therapeutic benefit.
• Of the 10 supplemental new indications with ratings by any organization, 3 (30%) were rated as clinically useful or having high added therapeutic benefit.

IN PRACTICE:

While innovative drug development in dermatology may have increased, “these findings also highlight opportunities to develop more truly innovative dermatologic agents, particularly for diseases with unmet therapeutic need,” the authors wrote.

SOURCE:

First author Samir Kamat, MD, of the Medical Education Department at Icahn School of Medicine at Mount Sinai, New York City, and corresponding author Ravi Gupta, MD, MSHP, of the Internal Medicine Division at Johns Hopkins University, Baltimore, Maryland, led the research. The study was published online as a research letter on December 20, 2023, in JAMA Dermatology.

LIMITATIONS:

They include the use of individual indications to assess clinical usefulness and benefit ratings. Many drugs, particularly supplemental indications, lacked such ratings. Reformulations of already marketed drugs or indications were not included.

DISCLOSURES:

Dr. Kamat and Dr. Gupta had no relevant disclosures. Three coauthors reported having received financial support outside of the submitted work.

A version of this article appeared on Medscape.com.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

Isotretinoin users have no increased risk of suicide or psychiatric conditions on a population level, a meta-analysis of 25 studies that included 1.6 million patients suggests.

Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.

The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I² [measuring heterogeneity] = 77%) in 11 studies.
 

Less likely to attempt suicide

Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I² = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I² = 23%) following treatment.

Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I² = 0%).

Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
 

“Two things can be true”

John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.

Dr. Barbieri

The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.

In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”

He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.

“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”

Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.

In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
 

What a meta-analysis might miss

In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.

They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”

Far from the “final word”

Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”

Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.

Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.

TOPLINE:

Use of Janus kinase (JAK) inhibitors is associated with a nearly fourfold increase in risk of acne compared with placebo, according to an analysis of 25 JAK inhibitor studies.

METHODOLOGY:

• Acne has been reported to be an adverse effect of JAK inhibitors, but not much is known about how common acne is overall and how incidence differs between different JAK inhibitors and the disease being treated.
• For the systematic review and meta-analysis, researchers identified 25 phase 2 or 3 randomized, controlled trials that reported acne as an adverse event associated with the use of JAK inhibitors.
• The study population included 10,839 participants (54% male, 46% female).
• The primary outcome was the incidence of acne following a period of JAK inhibitor use.

TAKEAWAY:

• Overall, the risk of acne was significantly higher among those treated with JAK inhibitors in comparison with patients given placebo in a pooled analysis (odds ratio [OR], 3.83).
• The risk of acne was highest with abrocitinib (OR, 13.47), followed by baricitinib (OR, 4.96), upadacitinib (OR, 4.79), deuruxolitinib (OR, 3.30), and deucravacitinib (OR, 2.64). By JAK inhibitor class, results were as follows: JAK1-specific inhibitors (OR, 4.69), combined JAK1 and JAK2 inhibitors (OR, 3.43), and tyrosine kinase 2 inhibitors (OR, 2.64).
• In a subgroup analysis, risk of acne was higher among patients using JAK inhibitors for dermatologic conditions in comparison with those using JAK inhibitors for nondermatologic conditions (OR, 4.67 vs 1.18).
• Age and gender had no apparent impact on the effect of JAK inhibitor use on acne risk.

IN PRACTICE:

“The occurrence of acne following treatment with certain classes of JAK inhibitors is of potential concern, as this adverse effect may jeopardize treatment adherence among some patients,” the researchers wrote. More studies are needed “to characterize the underlying mechanism of acne with JAK inhibitor use and to identify best practices for treatment,” they added.

SOURCE:

The lead author was Jeremy Martinez, MPH, of Harvard Medical School, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The review was limited by the variable classification and reporting of acne across studies, the potential exclusion of relevant studies, and the small number of studies for certain drugs.

DISCLOSURES:

The studies were mainly funded by the pharmaceutical industry. Mr. Martinez disclosed no relevant financial relationships. Several coauthors have ties with Dexcel Pharma Technologies, AbbVie, Concert, Pfizer, 3Derm Systems, Incyte, Aclaris, Eli Lilly, Concert, Equillium, ASLAN, ACOM, and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Use of Janus kinase (JAK) inhibitors is associated with a nearly fourfold increase in risk of acne compared with placebo, according to an analysis of 25 JAK inhibitor studies.

METHODOLOGY:

• Acne has been reported to be an adverse effect of JAK inhibitors, but not much is known about how common acne is overall and how incidence differs between different JAK inhibitors and the disease being treated.
• For the systematic review and meta-analysis, researchers identified 25 phase 2 or 3 randomized, controlled trials that reported acne as an adverse event associated with the use of JAK inhibitors.
• The study population included 10,839 participants (54% male, 46% female).
• The primary outcome was the incidence of acne following a period of JAK inhibitor use.

TAKEAWAY:

• Overall, the risk of acne was significantly higher among those treated with JAK inhibitors in comparison with patients given placebo in a pooled analysis (odds ratio [OR], 3.83).
• The risk of acne was highest with abrocitinib (OR, 13.47), followed by baricitinib (OR, 4.96), upadacitinib (OR, 4.79), deuruxolitinib (OR, 3.30), and deucravacitinib (OR, 2.64). By JAK inhibitor class, results were as follows: JAK1-specific inhibitors (OR, 4.69), combined JAK1 and JAK2 inhibitors (OR, 3.43), and tyrosine kinase 2 inhibitors (OR, 2.64).
• In a subgroup analysis, risk of acne was higher among patients using JAK inhibitors for dermatologic conditions in comparison with those using JAK inhibitors for nondermatologic conditions (OR, 4.67 vs 1.18).
• Age and gender had no apparent impact on the effect of JAK inhibitor use on acne risk.

IN PRACTICE:

“The occurrence of acne following treatment with certain classes of JAK inhibitors is of potential concern, as this adverse effect may jeopardize treatment adherence among some patients,” the researchers wrote. More studies are needed “to characterize the underlying mechanism of acne with JAK inhibitor use and to identify best practices for treatment,” they added.

SOURCE:

The lead author was Jeremy Martinez, MPH, of Harvard Medical School, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The review was limited by the variable classification and reporting of acne across studies, the potential exclusion of relevant studies, and the small number of studies for certain drugs.

DISCLOSURES:

The studies were mainly funded by the pharmaceutical industry. Mr. Martinez disclosed no relevant financial relationships. Several coauthors have ties with Dexcel Pharma Technologies, AbbVie, Concert, Pfizer, 3Derm Systems, Incyte, Aclaris, Eli Lilly, Concert, Equillium, ASLAN, ACOM, and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Use of Janus kinase (JAK) inhibitors is associated with a nearly fourfold increase in risk of acne compared with placebo, according to an analysis of 25 JAK inhibitor studies.

METHODOLOGY:

• Acne has been reported to be an adverse effect of JAK inhibitors, but not much is known about how common acne is overall and how incidence differs between different JAK inhibitors and the disease being treated.
• For the systematic review and meta-analysis, researchers identified 25 phase 2 or 3 randomized, controlled trials that reported acne as an adverse event associated with the use of JAK inhibitors.
• The study population included 10,839 participants (54% male, 46% female).
• The primary outcome was the incidence of acne following a period of JAK inhibitor use.

TAKEAWAY:

• Overall, the risk of acne was significantly higher among those treated with JAK inhibitors in comparison with patients given placebo in a pooled analysis (odds ratio [OR], 3.83).
• The risk of acne was highest with abrocitinib (OR, 13.47), followed by baricitinib (OR, 4.96), upadacitinib (OR, 4.79), deuruxolitinib (OR, 3.30), and deucravacitinib (OR, 2.64). By JAK inhibitor class, results were as follows: JAK1-specific inhibitors (OR, 4.69), combined JAK1 and JAK2 inhibitors (OR, 3.43), and tyrosine kinase 2 inhibitors (OR, 2.64).
• In a subgroup analysis, risk of acne was higher among patients using JAK inhibitors for dermatologic conditions in comparison with those using JAK inhibitors for nondermatologic conditions (OR, 4.67 vs 1.18).
• Age and gender had no apparent impact on the effect of JAK inhibitor use on acne risk.

IN PRACTICE:

“The occurrence of acne following treatment with certain classes of JAK inhibitors is of potential concern, as this adverse effect may jeopardize treatment adherence among some patients,” the researchers wrote. More studies are needed “to characterize the underlying mechanism of acne with JAK inhibitor use and to identify best practices for treatment,” they added.

SOURCE:

The lead author was Jeremy Martinez, MPH, of Harvard Medical School, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The review was limited by the variable classification and reporting of acne across studies, the potential exclusion of relevant studies, and the small number of studies for certain drugs.

DISCLOSURES:

The studies were mainly funded by the pharmaceutical industry. Mr. Martinez disclosed no relevant financial relationships. Several coauthors have ties with Dexcel Pharma Technologies, AbbVie, Concert, Pfizer, 3Derm Systems, Incyte, Aclaris, Eli Lilly, Concert, Equillium, ASLAN, ACOM, and Boehringer Ingelheim.
 

A version of this article appeared on Medscape.com.

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.

The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.

The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.

The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.

The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.

The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.

The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.

The Food and Drug Administration has approved a topical combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide for the treatment of acne vulgaris in patients aged 12 years and older, according to a press release from the manufacturer.

The combination of an antibiotic, a retinoid, and an antibacterial in a gel formulation will be marketed as Cabtreo, and is expected to be available in the first quarter of 2024, according to Ortho Dermatologics.

The treatment was evaluated in a pair of phase 3 multicenter, randomized, controlled trials of 363 patients with moderate to severe acne, according to the company. Approximately 50% of patients across both studies met the primary endpoint of treatment success after 12 weeks of daily use, compared with 24.9% and 20.4% of placebo patients on vehicle in studies 1 and 2, respectively. Treatment success in both studies was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) with scores of clear (0) or almost clear (1), and absolute change from baseline in both inflammatory and noninflammatory lesions. Patients were evaluated at 2, 4, 8, and 12 weeks.

Patients in the treatment groups for both studies had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12, compared with those in the vehicle group. The mean reductions with the treatment vs. vehicle were 75.7% vs. 59.6% and 72.7% vs. 47.6% for inflammatory and noninflammatory lesions, respectively, in study 1, and 80.1% vs. 56.2% and 73.3% vs. 49.0% for inflammatory and noninflammatory lesions, respectively, in study 2.

The most common adverse events were erythema, application-site reactions, pain, irritation, exfoliation, and dermatitis, all of which were more common in the treatment groups vs. the placebo groups.