Efficacy and Safety of Clascoterone Cream 1% and Adapalene Gel 0.3% in Patients With Acne

BACKGROUND: Clascoterone cream 1% is a topical androgen receptor inhibitor approved for the treatment of acne vulgaris in patients ≥12 years of age. The American Academy of Dermatology recommends topical combination therapy using medications that target different mechanisms of acne pathogenesis. This 20-week, open-label, pilot study (NCT06336603) evaluated the efficacy and safety of clascoterone cream 1% combined with adapalene gel 0.3% in patients with acne. METHODS: Patients aged ≥12 years with moderate-to-severe acne applied clascoterone cream 1% twice daily and adapalene gel 0.3% once daily for 16 weeks. Efficacy assessments included Investigator's Global Assessment (IGA) score; inflammatory, noninflammatory, and total lesion counts; and Dermatology Life Quality Index (DLQI) through week 16. Tolerability and safety were assessed from local skin reactions and adverse events through week 20. RESULTS: Twenty patients were enrolled; 17 completed the study (female, 53%; mean [standard deviation (SD)] age, 22 [10] years). At week 16, 65% of patients achieved an IGA score of clear (0) or almost clear (1). From baseline to week 16, there were significant reductions in lesion counts (mean [SD] percent reduction: inflammatory, 90.5 [10.1]; noninflammatory, 84.8 [13.5]; total, 87.3 [11.4]; all P<0.001) and DLQI score (mean [SD] reduction, 3.7 [6.2]; P=0.02). Treatment was well tolerated, with most local skin reactions reported as absent or trace, and no adverse events reported. CONCLUSIONS: This open-label pilot study shows promising results for combination treatment with clascoterone cream 1% and adapalene gel 0.3% for the treatment of patients with acne.  .