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

Abstract

Introduction: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination acne topical—demonstrated superior efficacy to vehicle and component dyads, with favorable safety/tolerability in phase 2 and phase 3 trials.^1,2 To better understand CAB efficacy and safety in patients with darker skin phototypes, this post hoc analysis included participants who self-identified as “Black or African American” (hereafter referred to as Black).

Methods: Data were pooled from two phase 2 and two phase 3, double-blind, 12-week trials (NCT03170388, NCT04892706, NCT04214639, NCT04214652). Eligible participants aged ≥9 years (≥12 years in NCT04892706) were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and  inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed.

Results: Of 1115 participants randomized to CAB or vehicle, 156 (14%) were Black. At week 12, 32.0% of CAB-treated participants achieved treatment success vs 18.3% with vehicle (P=0.07). Inflammatory and noninflammatory lesion reductions were significantly greater with CAB vs vehicle (68.8% vs 51.4% and 57.8% vs 45.5%, respectively; P<0.05, both). TEAE severity was mild-to-moderate, and rates were lower than observed in the overall trial populations (20.5% vs 24.6-36.2%). Hyperpigmentation mean scores remained at/below baseline value (0.7; 1=mild).

Conclusions: CAB gel was efficacious, well tolerated, and associated with no mean increases in hyperpigmentation in Black participants with acne. This post hoc analysis adds valuable information to the limited literature evaluating fixed-dose combination treatment in Black individuals.

Funding: Ortho Dermatologics.