A topical antiandrogen agent has been shown to be effective and with few side effects in patients with moderate to severe facial acne.
Two identical RCTs, comprising 1,440 US and European patients from age 10 to 58 years, compared 1% clascoterone twice daily for 12 weeks with the vehicle cream.
The studies, published together in JAMA Dermatology, showed treatment success rates with clascoterone of 18.4% and 20.3% compared to 9.0% and 6.5% in the control groups.
There was also a greater reduction in inflammatory lesions in the two clascoterone groups than in the two control groups (44.8% and 46.9% v 36.5% and 29.6%) and similarly for noninflammatory lesions (30.6% and 29.3% v 21.6% and 15.6%).
The authors said clascoterone was well tolerated with treatment-related effects such as mild application site pain, dryness, erythema and hypersensitivity.
“Treatment adherence was approximately 90% for patients applying clascoterone cream, 1%, which suggests that the treatment regimen is easy to follow and suitable for general clinical practice,” they said.
However an editorial highlighted the potential for adrenal suppression with clascoterone as has been previously shown in a previous phase 2 study in patients using the treatment for face, shoulders, upper chest and upper back acne.
“While no clinical symptoms of adrenal suppression were observed in this study or the phase 3 trials, this potential adverse effect may be important to consider, particularly when using larger quantities of clascoterone,” the editorial said.
WA dermatologist Associate Professor Kurt Gebauer, co-chair of All About Acne, said the studies were of interest and while the response rates were not dramatic, clascoterone may be particularly useful for women with acne.
“We are seeing more and more women now than we have ever seen before… probably 10% [of patients] are women in their 20s and 30s with annoying, grumbling acne. So there is a big unmet need for topical therapies.”
He said many women didn’t want to take antibiotics because of side effects such as thrush. They were also concerned about clots and breast cancer risk with some of the oral contraceptives and other antiandrogens like spironolactone took a long time to work.
“Certainly a significant number of women won’t or can’t take systemic anti-androgens.”
“So my comment would be that there is a large unmet need and we are enthusiastic about any new topical treatments that work in a different way.”
“If that was available for me to trial, I would be looking at it in females first and then maybe expanding the group.”
Associate Professor Gebauer noted the comments about adrenal suppression might be a consideration as acne treatment often went on for months.
However clascoterone’s potential use in women with acne would be localised to small problem areas such as the chin.
He said head-to-head studies with other agents and more trials with larger numbers of patients were required.