Clascoterone: a new topical anti-androgen for acne management.

Clascoterone is an androgen receptor inhibitor which has been approved by the United States Food and Drug Administration for the topical treatment of acne vulgaris in patients 12 years of age and older. It competes with androgens, especially dihydrotestosterone, for androgen-receptor binding and limits their binding, thus inhibiting downstream signaling of pathways involved in the pathogenesis of acne. It inhibits androgen receptor-regulated gene transcription, and antagonizes lipid and inflammatory cytokine production in a dose-dependent manner in human primary sebocytes. Clascoterone is commercially available as 1% (10 mg/g) cream. Adverse effects of topical clascoterone are mild and infrequent, and are mostly limited to local skin reactions. Long-term safety studies have shown an absence of systemic antiandrogenic effects like reduced libido or feminization in male participants. Clascoterone seems a promising topical drug with a novel mechanism of action that could be added to the armamentarium of therapies for acne.