Efficacy and Safety of Clascoterone Cream 1% for Acne Are Independent of Age and Sex

Acne vulgaris is an inflammatory skin condition affecting adolescents and adults of both sexes. Clascoterone cream 1% is indicated for the topical treatment of acne vulgaris in patients ≥12 years of age based on the results of two Phase 3 trials (NCT02608450 and NCT02608476). This post hoc analysis evaluated the efficacy and safety of clascoterone cream 1% in patient subgroups defined by age (adolescent vs adult) and sex (male vs female). Patients ≥12 years of age with mild-to-moderate acne applied clascoterone cream 1% or vehicle twice daily for 12 weeks. Efficacy was assessed from Investigator’s Global Assessment (IGA) treatment success and inflammatory, noninflammatory, and total lesion counts, and safety from frequency and severity of adverse events. Treatment with clascoterone cream 1% vs vehicle resulted in significantly greater IGA treatment success rates for all subgroups: at week 12, 47/287 (16.4%) vs 12/306 (3.9%) adolescent, 77/330 (23.3%) vs 29/309 (9.4%) adult, 32/226 (14.2%) vs 13/252 (5.2%) male, and 92/391 (23.5%) vs 28/363 (7.7%) female patients achieved IGA treatment success. Patients treated with clascoterone cream 1% vs vehicle in all subgroups also experienced significantly greater lesion count reductions. From baseline to week 12, clascoterone cream 1% treatment resulted in significantly larger reductions in lesion counts in adult vs adolescent patients; there were no statistically significant differences between male and female patients. Adverse events were similar across subgroups. These results further support the efficacy and tolerability of clascoterone cream 1% across the spectrum of patients ≥12 years of age with acne vulgaris.