Efficacy and Safety of Clascoterone Cream 1% and Clindamycin 1.2%/Benzoyl Peroxide 5% Gel Treatment in Patients With Acne

BACKGROUND: Clascoterone cream 1% is a topical androgen receptor inhibitor approved to treat acne vulgaris in patients ≥12 years of age. The American Academy of Dermatology recommends combining topical therapies that target different mechanisms of acne pathogenesis as first-line treatment for acne. This 16-week, open-label pilot study evaluated the efficacy and safety of clascoterone cream 1% combined with clindamycin 1.2%/benzoyl peroxide 5% gel in patients with acne. METHODS: Patients aged ≥12 years with moderate acne applied clascoterone cream 1% twice daily and clindamycin 1.2%/benzoyl peroxide 5% gel once daily for 12 weeks. Assessments included Investigator's Global Assessment (IGA) score; inflammatory, noninflammatory, and total lesion counts; Dermatology Life Quality Index (DLQI) score; tolerability (through local skin reactions); and safety (through adverse events) through week 16. RESULTS: Nine patients were enrolled in the study (female, 56%; White, 56%; mean [standard deviation (SD)] age, 33 [17] years). At week 16, all patients had an IGA score of clear (0) or almost clear (1); from baseline to week 16, there were significant decreases in lesion counts (mean [SD] percent reduction; inflammatory: 96.4 [6.0], P=0.007; noninflammatory: 86.1 [15.3], P=0.009; total: 92.0 [8.2], P=0.008) and DLQI scores (mean [SD] reduction, 3.1 [2.1], P=0.014). The treatment was well tolerated with no adverse events reported through week 16. CONCLUSIONS: Based on data from 9 patients, combination treatment with clascoterone cream 1% and clindamycin 1.2%/benzoyl peroxide 5% gel is safe and effective to treat patients with acne.  .