Androgens and Acne: Perspectives on Clascoterone, the First Topical Androgen Receptor Antagonist

In a review of clascoterone, the first FDA-approved topical androgen receptor antagonist for acne treatment, it was found to be effective and safe in a Phase III clinical trial with 1,440 participants. The trial showed significant reductions in both non-inflammatory and inflammatory acne lesions at week 12, with 18.4% and 20.3% of patients achieving treatment success, compared to 9.0% and 6.5% with a placebo. Clascoterone works by binding to androgen receptors in sebaceous glands and hair follicles, reducing sebum production and acne without systemic effects. Only 13 mild treatment emergent adverse events were reported, and no systemic anti-androgen exposure was observed. While the study was limited by small subgroup sample sizes and did not consider the impact of other acne therapies, clascoterone is considered a promising new treatment for acne and is also being investigated for androgenetic alopecia.