Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Asian Participants With Moderate to Severe Acne

Abstract

Introduction: Acne vulgaris is a common skin condition with significant impact on Asian patients. Because clinical presentation of acne varies across different populations, it is important to consider patient demographics to improve treatment outcomes. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only triple-combination formulation approved for acne. In phase 2 and 3 clinical trials of participants with moderate to severe acne, CAB was more efficacious than vehicle (treatment success: ~50% vs 8%-25%; inflammatory lesion [IL]/noninflammatory lesion [NL] reductions: 71%-80% vs 46%-60%) with favorable safety/tolerability. This post hoc analysis evaluated the efficacy and safety of CAB in Asian participants.

Methods: Data were pooled from two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week trials in which 1115 participants aged ≥9 years (≥12 in NCT04892706) with moderate to severe acne were randomized to once-daily CAB or vehicle gel; additional randomization arms are not included here. Analyses were performed using data from participants who self-identified as Asian. Endpoints included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in IL/NL counts at week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed.

Results: A total of 96 Asian participants were included in this analysis (CAB, n=47; vehicle gel, n=49). At week 12, 66.5% of CAB-treated participants achieved treatment success, which was significantly greater compared with vehicle-treated participants (23.4%; P<0.001). CAB-treated participants experienced 87.7% reductions in IL and 80.3% reductions in NL counts, significantly greater versus vehicle (58.3% and 55.7%, respectively; P≤0.001, both). Rate of TEAEs in CAB-treated Asian participants was similar to those of the overall study populations (27.7% vs 24.6%-36.2%). Most TEAEs were mild or moderate severity and no serious AEs occurred. Hyperpigmentation mean scores stayed below the baseline value (0.7; 1=mild) at all time points.

Conclusions: In this pooled analysis, 12 weeks of once-daily CAB treatment in Asian participants with moderate to severe acne led to a treatment success rate of 66.5%, and >80% acne lesion reductions, with favorable safety/tolerability. These improvements are numerically greater than results in the overall study populations, indicating that triple-combination CAB is well suited for acne treatment in Asian patients