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Options for acne treatment continue to advance
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
AT THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
FDA advisory committee supports birth control patch approval
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
Most of the committee members based their decisions on the need for additional contraceptive options for patients. However, most also expressed concerns about its efficacy and offered suggestions for product labeling that called attention to high rates of unintended pregnancies and increased risk of venous thromboembolism (VTE) in obese women.
The agency’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed safety and efficacy data for AG200-15, a combined hormonal contraceptive patch developed by Agile Therapeutics. The treatment regimen involves application of a patch to the abdomen, buttock, or upper torso, and the patch is changed weekly for 3 weeks, followed by 1 week without a patch.
Elizabeth Garner, MD, consultant and former chief medical officer of Agile, presented study data on safety and effectiveness of the patch. The key study (known as Study 23) considered by the FDA included 1,736 women aged 35 years and younger. The primary efficacy endpoint was the pregnancy rate in the women who used the patch. Women reported sexual activity and back-up contraception use in e-diaries.
A total of 68 pregnancies occurred in the study population after 15,165 evaluable cycles, yielding an overall Pearl Index of 5.83 across all weight and body mass index groups. Historically, a Pearl Index of 5 has been the standard measure for effectiveness in contraceptive products, with lower being better. The index is defined as the number of pregnancies per 100 woman-years of product use. For example, a Pearl Index of 0.1 means that 1 in 1,000 women who use the same contraceptive method for 1 year becomes pregnant.
A subgroup analysis showed reduced efficacy in women with a higher BMI. The Pearl Index for women with a BMI of less than 30 kg/m2 (defined as nonobese) was 4.34, whereas in women with a BMI of 30 kg/m2 and higher (defined as obese), the index was 8.64, nearly double that of nonobese women. No significant differences in the index were noted based on race/ethnicity.
The company described the patch as filling a niche and providing an additional alternative for women seeking a noninvasive method of contraception. It proposed a limitation of use (LOU) as part of the product label that would provide detailed information on efficacy based on the Pearl Index for the different categories of BMI and would suggest that the patch may be less effective for women with obesity. Most of the committee members favored use of a LOU statement on the label, but some noted that it might limit prescriptions to nonobese women.
The committee expressed concern over the Pearl data in the study. The FDA has never approved a contraceptive product with a Pearl Index of greater than 5, said Yun Tang, PhD, a statistical reviewer for the agency’s Office of Translational Sciences, who presented the evaluation of the effectiveness of AG200-15.
Key safety concerns raised in discussion included the risk of venous thromboembolism and the risk of unscheduled bleeding. Both of those issues were significantly more common among obese women, said Nneka McNeal-Jackson, MD, clinical reviewer for the FDA, who presented details on the safety profile and risk-benefit considerations for the patch.
Overall, in Study 23, the incidence rate of VTE was 28/10,000 women-years, with cases in five participants. Four of those were deemed related to the patch, and all occurred in obese women.
Virginia C. “Jennie” Leslie, MD, of Oregon Health and Science University, Portland, voted no to recommending approval of the patch mainly because of efficacy concerns. “My goal is to do no harm, and I have concerns regarding efficacy and giving our patients a false sense of hope,” she said.
Even those members who voted yes expressed concerns about the efficacy data and VTE risk in obese women and recommended postmarketing studies and appropriate labeling to help clinicians in shared decision making with their patients.
Esther Eisenberg, MD, of the National Institutes of Health, noted that the patch fills a need, certainly for women with a BMI less than 30 kg/m2, and suggested that use be limited to women in that lower BMI category.
Other committee members suggested that the product not be restricted based on BMI, but rather that the LOU provide clear explanations of how effectiveness decreases as BMI increases.
David J. Margolis, MD, of the University of Pennsylvania, Philadelphia, opted to abstain from voting, in part based on concerns about the study design and a lack of additional data from the company.
FROM THE FDA
Major survey spotlights novel factors influencing acne
MADRID – Do you ask your acne patients if they use cannabis? And if they say yes, do you suggest they consider giving it up? Dermatologist Delphine Kerob, MD, believes you should.
In a late-breaker session at the annual congress of the European Academy of Dermatology and Venereology, she presented . One of the biggest surprises in this first-of-its-kind study was the finding of an association between cannabis use and acne: 21.1% of patients with physician-diagnosed acne were users, compared with 16.6% of controls without acne.
“I think as dermatologists we should ask these kinds of questions when we manage our patients because this may influence the course of their acne,” observed Dr. Kerob, who is the international medical director for Vichy Laboratories in Paris. The survey was sponsored by the company.
This was an Internet-based survey of 2,826 acne patients and 3,853 age- and sex-matched controls without acne. It was conducted in Canada, France, Germany, Italy, Brazil, and Russia.
The survey comprehensively addressed for the first time what lead investigator Brigitte Dreno, MD, PhD, professor and head of dermatology at Nantes (France) University Hospital and EADV Scientific Programming Committee Chair, has previously called the “acne exposome.” The exposome is essentially everything in a patient’s external and internal environment – other than genetics – that influences the occurrence and severity of the disease (J Eur Acad Dermatol Venereol. 2018 May;32[5]:812-9).
The survey probed the six major categories of exposome factors as defined by Dr. Dreno and coauthors: nutrition, air pollution, lifestyle and psychological factors, medications, skin care products, and climate. Here are the highlights:
Lifestyle and psychological factors. While cannabis use emerged as a novel factor linked to increased likelihood of acne, tobacco use was not – a surprising finding because other investigators had previously identified it as an acne trigger.
Feeling burdened by psychological stress was reported by 51% of acne patients and 29% of controls, for an adjusted 1.79-fold increased risk of acne.
Air pollution. Acne patients were significantly more likely to report exposure to solvent vapors, crude oil, tars, frying oil vapors, and living near an airport or close to factories with chimneys. Dr. Kerob noted that these findings are consistent with other investigators’ study of 189 residents of heavily polluted Mexico City or more pristine Cuernavaca, Mexico, with less pollution. The Mexico City cohort demonstrated an increased sebum excretion rate, lower levels of the antioxidants vitamin E and squalene in their sebum, and a less cohesive stratum corneum, along with a higher prevalence of atopic skin and facial seborrheic changes (Int J Cosmet Sci. 2015 Jun;37[3]:329-38).
Nutrition. This is a hot topic that acne patients have many questions about. Myths abound, as detailed by an expert panel including Dr. Dreno in an article entitled, “Acne and Nutrition: Hypotheses, Myths and Facts” (J Eur Acad Dermatol Venereol. 2018 Oct;32[10]:1631-7).
Dr. Kerob reported that the survey showed consumption of dairy products, probiotics, chocolate, cakes and other sweets, soft drinks, fruit juice, and whey protein were each associated with a significantly increased likelihood of acne .
Fifty-seven percent of acne patients indicated they consumed high-alcohol distilled spirits, compared with 43% of controls.
“We know that on our sebaceous glands, as well as on keratinocytes, we have receptors that will be activated by the impact of some nutrients,” she commented.
Among these receptors on sebaceous glands are the insulin growth factor–1 receptor, the leptin receptor, histamine receptors, receptors for substance P, peroxisome proliferator-activated receptors alpha, beta, and gamma, and androgen receptors, she added.
Medications. For Dr. Kerob, another surprise study finding was that 11.9% of acne patients had used an anabolic steroid- or testosterone-based hormonal drug within the previous 12 months, compared with 3.2% of controls without acne.
Cosmetic factors. The use of facial scrubs, harsh cleansers, and dermarollers was significantly more common among the acne patients.
Climate. Acne patients were more likely to live in hot and/or humid locations. For example, 24.6% of the acne group lived in a hot climate, versus 17.1% of controls.
“We think that identifying and reducing the impact of the exposome is very important for an adequate and holistic acne disease management,” the researcher concluded.
However, Eric Simpson, MD, rose from the audience to comment that he finds this plethora of associations to be of little use in advising his acne patients in clinical practice. For example, does cannabis use cause acne, or are acne patients more likely to be cannabis users as a means of coping with the social stigma surrounding their skin disease?
“I’d just caution about confounding association with causation. Let’s look at trials of removing that association to see if it actually improves acne before we make strong recommendations in the clinic,” urged Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.
“You’re perfectly right, there,” Dr. Kerob replied. “The methodology of our study can’t separate cause from effect. But as dermatologists, if we have patients with acne that’s resistant to treatment, we need to see if there are other factors that could worsen acne outcome. And we have patients asking us questions all the time about nutrition – now we have some answers that we can provide to those patients.”
The study was sponsored by Vichy Laboratories, and Dr. Kerob is an employee of the company.
MADRID – Do you ask your acne patients if they use cannabis? And if they say yes, do you suggest they consider giving it up? Dermatologist Delphine Kerob, MD, believes you should.
In a late-breaker session at the annual congress of the European Academy of Dermatology and Venereology, she presented . One of the biggest surprises in this first-of-its-kind study was the finding of an association between cannabis use and acne: 21.1% of patients with physician-diagnosed acne were users, compared with 16.6% of controls without acne.
“I think as dermatologists we should ask these kinds of questions when we manage our patients because this may influence the course of their acne,” observed Dr. Kerob, who is the international medical director for Vichy Laboratories in Paris. The survey was sponsored by the company.
This was an Internet-based survey of 2,826 acne patients and 3,853 age- and sex-matched controls without acne. It was conducted in Canada, France, Germany, Italy, Brazil, and Russia.
The survey comprehensively addressed for the first time what lead investigator Brigitte Dreno, MD, PhD, professor and head of dermatology at Nantes (France) University Hospital and EADV Scientific Programming Committee Chair, has previously called the “acne exposome.” The exposome is essentially everything in a patient’s external and internal environment – other than genetics – that influences the occurrence and severity of the disease (J Eur Acad Dermatol Venereol. 2018 May;32[5]:812-9).
The survey probed the six major categories of exposome factors as defined by Dr. Dreno and coauthors: nutrition, air pollution, lifestyle and psychological factors, medications, skin care products, and climate. Here are the highlights:
Lifestyle and psychological factors. While cannabis use emerged as a novel factor linked to increased likelihood of acne, tobacco use was not – a surprising finding because other investigators had previously identified it as an acne trigger.
Feeling burdened by psychological stress was reported by 51% of acne patients and 29% of controls, for an adjusted 1.79-fold increased risk of acne.
Air pollution. Acne patients were significantly more likely to report exposure to solvent vapors, crude oil, tars, frying oil vapors, and living near an airport or close to factories with chimneys. Dr. Kerob noted that these findings are consistent with other investigators’ study of 189 residents of heavily polluted Mexico City or more pristine Cuernavaca, Mexico, with less pollution. The Mexico City cohort demonstrated an increased sebum excretion rate, lower levels of the antioxidants vitamin E and squalene in their sebum, and a less cohesive stratum corneum, along with a higher prevalence of atopic skin and facial seborrheic changes (Int J Cosmet Sci. 2015 Jun;37[3]:329-38).
Nutrition. This is a hot topic that acne patients have many questions about. Myths abound, as detailed by an expert panel including Dr. Dreno in an article entitled, “Acne and Nutrition: Hypotheses, Myths and Facts” (J Eur Acad Dermatol Venereol. 2018 Oct;32[10]:1631-7).
Dr. Kerob reported that the survey showed consumption of dairy products, probiotics, chocolate, cakes and other sweets, soft drinks, fruit juice, and whey protein were each associated with a significantly increased likelihood of acne .
Fifty-seven percent of acne patients indicated they consumed high-alcohol distilled spirits, compared with 43% of controls.
“We know that on our sebaceous glands, as well as on keratinocytes, we have receptors that will be activated by the impact of some nutrients,” she commented.
Among these receptors on sebaceous glands are the insulin growth factor–1 receptor, the leptin receptor, histamine receptors, receptors for substance P, peroxisome proliferator-activated receptors alpha, beta, and gamma, and androgen receptors, she added.
Medications. For Dr. Kerob, another surprise study finding was that 11.9% of acne patients had used an anabolic steroid- or testosterone-based hormonal drug within the previous 12 months, compared with 3.2% of controls without acne.
Cosmetic factors. The use of facial scrubs, harsh cleansers, and dermarollers was significantly more common among the acne patients.
Climate. Acne patients were more likely to live in hot and/or humid locations. For example, 24.6% of the acne group lived in a hot climate, versus 17.1% of controls.
“We think that identifying and reducing the impact of the exposome is very important for an adequate and holistic acne disease management,” the researcher concluded.
However, Eric Simpson, MD, rose from the audience to comment that he finds this plethora of associations to be of little use in advising his acne patients in clinical practice. For example, does cannabis use cause acne, or are acne patients more likely to be cannabis users as a means of coping with the social stigma surrounding their skin disease?
“I’d just caution about confounding association with causation. Let’s look at trials of removing that association to see if it actually improves acne before we make strong recommendations in the clinic,” urged Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.
“You’re perfectly right, there,” Dr. Kerob replied. “The methodology of our study can’t separate cause from effect. But as dermatologists, if we have patients with acne that’s resistant to treatment, we need to see if there are other factors that could worsen acne outcome. And we have patients asking us questions all the time about nutrition – now we have some answers that we can provide to those patients.”
The study was sponsored by Vichy Laboratories, and Dr. Kerob is an employee of the company.
MADRID – Do you ask your acne patients if they use cannabis? And if they say yes, do you suggest they consider giving it up? Dermatologist Delphine Kerob, MD, believes you should.
In a late-breaker session at the annual congress of the European Academy of Dermatology and Venereology, she presented . One of the biggest surprises in this first-of-its-kind study was the finding of an association between cannabis use and acne: 21.1% of patients with physician-diagnosed acne were users, compared with 16.6% of controls without acne.
“I think as dermatologists we should ask these kinds of questions when we manage our patients because this may influence the course of their acne,” observed Dr. Kerob, who is the international medical director for Vichy Laboratories in Paris. The survey was sponsored by the company.
This was an Internet-based survey of 2,826 acne patients and 3,853 age- and sex-matched controls without acne. It was conducted in Canada, France, Germany, Italy, Brazil, and Russia.
The survey comprehensively addressed for the first time what lead investigator Brigitte Dreno, MD, PhD, professor and head of dermatology at Nantes (France) University Hospital and EADV Scientific Programming Committee Chair, has previously called the “acne exposome.” The exposome is essentially everything in a patient’s external and internal environment – other than genetics – that influences the occurrence and severity of the disease (J Eur Acad Dermatol Venereol. 2018 May;32[5]:812-9).
The survey probed the six major categories of exposome factors as defined by Dr. Dreno and coauthors: nutrition, air pollution, lifestyle and psychological factors, medications, skin care products, and climate. Here are the highlights:
Lifestyle and psychological factors. While cannabis use emerged as a novel factor linked to increased likelihood of acne, tobacco use was not – a surprising finding because other investigators had previously identified it as an acne trigger.
Feeling burdened by psychological stress was reported by 51% of acne patients and 29% of controls, for an adjusted 1.79-fold increased risk of acne.
Air pollution. Acne patients were significantly more likely to report exposure to solvent vapors, crude oil, tars, frying oil vapors, and living near an airport or close to factories with chimneys. Dr. Kerob noted that these findings are consistent with other investigators’ study of 189 residents of heavily polluted Mexico City or more pristine Cuernavaca, Mexico, with less pollution. The Mexico City cohort demonstrated an increased sebum excretion rate, lower levels of the antioxidants vitamin E and squalene in their sebum, and a less cohesive stratum corneum, along with a higher prevalence of atopic skin and facial seborrheic changes (Int J Cosmet Sci. 2015 Jun;37[3]:329-38).
Nutrition. This is a hot topic that acne patients have many questions about. Myths abound, as detailed by an expert panel including Dr. Dreno in an article entitled, “Acne and Nutrition: Hypotheses, Myths and Facts” (J Eur Acad Dermatol Venereol. 2018 Oct;32[10]:1631-7).
Dr. Kerob reported that the survey showed consumption of dairy products, probiotics, chocolate, cakes and other sweets, soft drinks, fruit juice, and whey protein were each associated with a significantly increased likelihood of acne .
Fifty-seven percent of acne patients indicated they consumed high-alcohol distilled spirits, compared with 43% of controls.
“We know that on our sebaceous glands, as well as on keratinocytes, we have receptors that will be activated by the impact of some nutrients,” she commented.
Among these receptors on sebaceous glands are the insulin growth factor–1 receptor, the leptin receptor, histamine receptors, receptors for substance P, peroxisome proliferator-activated receptors alpha, beta, and gamma, and androgen receptors, she added.
Medications. For Dr. Kerob, another surprise study finding was that 11.9% of acne patients had used an anabolic steroid- or testosterone-based hormonal drug within the previous 12 months, compared with 3.2% of controls without acne.
Cosmetic factors. The use of facial scrubs, harsh cleansers, and dermarollers was significantly more common among the acne patients.
Climate. Acne patients were more likely to live in hot and/or humid locations. For example, 24.6% of the acne group lived in a hot climate, versus 17.1% of controls.
“We think that identifying and reducing the impact of the exposome is very important for an adequate and holistic acne disease management,” the researcher concluded.
However, Eric Simpson, MD, rose from the audience to comment that he finds this plethora of associations to be of little use in advising his acne patients in clinical practice. For example, does cannabis use cause acne, or are acne patients more likely to be cannabis users as a means of coping with the social stigma surrounding their skin disease?
“I’d just caution about confounding association with causation. Let’s look at trials of removing that association to see if it actually improves acne before we make strong recommendations in the clinic,” urged Dr. Simpson, professor of dermatology at Oregon Health & Science University, Portland.
“You’re perfectly right, there,” Dr. Kerob replied. “The methodology of our study can’t separate cause from effect. But as dermatologists, if we have patients with acne that’s resistant to treatment, we need to see if there are other factors that could worsen acne outcome. And we have patients asking us questions all the time about nutrition – now we have some answers that we can provide to those patients.”
The study was sponsored by Vichy Laboratories, and Dr. Kerob is an employee of the company.
REPORTING FROM EADV 2019
FDA approves minocycline foam for moderate, severe acne
The Food and Drug Administration has vulgaris in adults and pediatric patients aged at least 9 years.
FDA approval was based on three phase 3, 12-week, multicenter, randomized, double-blind, vehicle-controlled studies of patients with moderate to severe acne vulgaris who were treated once daily with minocycline 4% plus vehicle or vehicle alone, according to a press release from the manufacturer, Foamix Pharmaceuticals. In all three studies, patients receiving minocycline had a reduction in the number of inflammatory lesions, compared with vehicle alone; in two studies, patients in the minocycline groups had significantly improved Investigator’s Global Assessment scores.
The most commonly reported adverse event reported during the trials was headache. No serious adverse events were reported. The company says it is expected to be available in January 2020.
Find the prescribing information on the FDA website.
The Food and Drug Administration has vulgaris in adults and pediatric patients aged at least 9 years.
FDA approval was based on three phase 3, 12-week, multicenter, randomized, double-blind, vehicle-controlled studies of patients with moderate to severe acne vulgaris who were treated once daily with minocycline 4% plus vehicle or vehicle alone, according to a press release from the manufacturer, Foamix Pharmaceuticals. In all three studies, patients receiving minocycline had a reduction in the number of inflammatory lesions, compared with vehicle alone; in two studies, patients in the minocycline groups had significantly improved Investigator’s Global Assessment scores.
The most commonly reported adverse event reported during the trials was headache. No serious adverse events were reported. The company says it is expected to be available in January 2020.
Find the prescribing information on the FDA website.
The Food and Drug Administration has vulgaris in adults and pediatric patients aged at least 9 years.
FDA approval was based on three phase 3, 12-week, multicenter, randomized, double-blind, vehicle-controlled studies of patients with moderate to severe acne vulgaris who were treated once daily with minocycline 4% plus vehicle or vehicle alone, according to a press release from the manufacturer, Foamix Pharmaceuticals. In all three studies, patients receiving minocycline had a reduction in the number of inflammatory lesions, compared with vehicle alone; in two studies, patients in the minocycline groups had significantly improved Investigator’s Global Assessment scores.
The most commonly reported adverse event reported during the trials was headache. No serious adverse events were reported. The company says it is expected to be available in January 2020.
Find the prescribing information on the FDA website.
New mechanisms, therapies for acne considered
SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.
Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.
One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”
She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.
A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).
The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.
If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.
Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).
“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.
Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.
Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.
This publication and Global Academy for Medical Education are owned by the same parent company.
SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.
Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.
One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”
She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.
A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).
The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.
If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.
Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).
“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.
Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.
Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.
This publication and Global Academy for Medical Education are owned by the same parent company.
SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.
Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.
One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”
She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.
A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).
The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.
If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.
Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).
“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.
Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.
Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.
This publication and Global Academy for Medical Education are owned by the same parent company.
EXPERT ANALYSIS FROM COASTAL DERM
Holy basil: A member of the Ocimum family
At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.
O. sanctum (O. tenuiflorum)
Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.1,2
In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.3
O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.4 Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.2
Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.1,5
Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.6
A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.7
O. gratissimum
O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.8
In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.9
In 2009, Nweze and Eze demonstrated that the ethanolic extract of the leaves of O. gratissimum displayed antibacterial activity, supporting its use in traditional medicine as well as a food spice that does not undermine conventional antibiotics, as is thought in some rural communities throughout the world.8O. gratissimum is a key ingredient of a topical cream formulation that is one component of a complete skin care line recently found to be effective in treating mild to moderate acne. The line includes an oral supplement for males, another for females, and the topical cream, which contains O. gratissimum and keratolytic ingredients (that is, salicylic acid, gluconolactone, and complex alpha-hydroxy acids). In the double-blind clinical trial, most patients were found to have exhibited satisfactory clinical responses according to the Global Acne Grading System.10
In 2015, Keziah et al. found that topical creams formulated with O. gratissimum and Lantana camara crude extracts and fractions were effective as mosquito repellents and might serve as natural alternatives to conventional products.11
O. basilicum
Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.12
Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.13,14
Conclusion
Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at dermnews@mdedge.com
References
1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.
2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.
3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.
4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.
5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.
6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.
7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.
8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.
9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.
10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.
11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.
12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.
13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.
14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.
O. sanctum (O. tenuiflorum)
Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.1,2
In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.3
O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.4 Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.2
Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.1,5
Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.6
A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.7
O. gratissimum
O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.8
In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.9
In 2009, Nweze and Eze demonstrated that the ethanolic extract of the leaves of O. gratissimum displayed antibacterial activity, supporting its use in traditional medicine as well as a food spice that does not undermine conventional antibiotics, as is thought in some rural communities throughout the world.8O. gratissimum is a key ingredient of a topical cream formulation that is one component of a complete skin care line recently found to be effective in treating mild to moderate acne. The line includes an oral supplement for males, another for females, and the topical cream, which contains O. gratissimum and keratolytic ingredients (that is, salicylic acid, gluconolactone, and complex alpha-hydroxy acids). In the double-blind clinical trial, most patients were found to have exhibited satisfactory clinical responses according to the Global Acne Grading System.10
In 2015, Keziah et al. found that topical creams formulated with O. gratissimum and Lantana camara crude extracts and fractions were effective as mosquito repellents and might serve as natural alternatives to conventional products.11
O. basilicum
Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.12
Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.13,14
Conclusion
Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at dermnews@mdedge.com
References
1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.
2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.
3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.
4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.
5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.
6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.
7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.
8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.
9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.
10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.
11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.
12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.
13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.
14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.
O. sanctum (O. tenuiflorum)
Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.1,2
In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.3
O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.4 Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.2
Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.1,5
Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.6
A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.7
O. gratissimum
O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.8
In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.9
In 2009, Nweze and Eze demonstrated that the ethanolic extract of the leaves of O. gratissimum displayed antibacterial activity, supporting its use in traditional medicine as well as a food spice that does not undermine conventional antibiotics, as is thought in some rural communities throughout the world.8O. gratissimum is a key ingredient of a topical cream formulation that is one component of a complete skin care line recently found to be effective in treating mild to moderate acne. The line includes an oral supplement for males, another for females, and the topical cream, which contains O. gratissimum and keratolytic ingredients (that is, salicylic acid, gluconolactone, and complex alpha-hydroxy acids). In the double-blind clinical trial, most patients were found to have exhibited satisfactory clinical responses according to the Global Acne Grading System.10
In 2015, Keziah et al. found that topical creams formulated with O. gratissimum and Lantana camara crude extracts and fractions were effective as mosquito repellents and might serve as natural alternatives to conventional products.11
O. basilicum
Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.12
Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.13,14
Conclusion
Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at dermnews@mdedge.com
References
1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.
2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.
3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.
4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.
5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.
6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.
7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.
8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.
9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.
10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.
11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.
12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.
13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.
14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
Infographic: Monitoring Acne Patients on Oral Therapy Survey Results and Practice Recommendations
FDA approves trifarotene for treating acne
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
The Food and Drug Administration has approved trifarotene cream 0.005% for the treatment of acne vulgaris. The product is manufactured by Galderma under the brand name Aklief.
The approval was based on data from a pair of phase 3, randomized trials including 2,420 patients aged 9 years and older. The trials evaluated the effectiveness of the cream in a once-daily topical dose for facial and truncal acne at 12 weeks. Patients showed a significant reduction in the number of inflammatory lesions as early as 2 weeks on the face (including forehead cheeks, nose, and chin) and as early as 4 weeks on the trunk (including back, chest, and shoulders), compared with a control cream. The most common treatment-emergent adverse events were pain, dryness, discoloration, or rash at the site of application. Some patients also reported sunburn.
The complete study findings were published in the June issue of the Journal of the American Academy of Dermatology.
The studies, funded by Galderma, “showed that once-daily trifarotene cream appears effective and safe, with manageable local tolerability, for the treatment for facial and truncal acne,” wrote lead author Jerry Tan, MD, of the University of Western Ontario, London, and colleagues. “The studies provide substantial evidence to support use of this new topical retinoid in facial and truncal acne,” the researchers wrote.
Trifarotene is designed to target the retinoic acid receptor gamma, the most common retinoic acid receptor in the skin, and is the first new retinoid to be approved by the FDA in approximately 2 decades, according to a press release from Galderma.
The product is expected to be available in the United States in November 2019 in a 45-g pump.
Antibiotic Resistance: What the Dermatologist Needs to Know
Questions include:
What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?
What can dermatologists do to slow the development of antibiotic resistance?
What is the mutant selection window?
How does the mutant selection window apply to topical antibiotics?
Questions include:
What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?
What can dermatologists do to slow the development of antibiotic resistance?
What is the mutant selection window?
How does the mutant selection window apply to topical antibiotics?
Questions include:
What is the potential magnitude of concern regarding antibiotic resistance? Is it clinically relevant to dermatologists in their day-to-day practice?
What can dermatologists do to slow the development of antibiotic resistance?
What is the mutant selection window?
How does the mutant selection window apply to topical antibiotics?
