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

<h4>Objective</h4>Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel-the only approved fixed-dose, triple-combination acne treatment-demonstrated superior efficacy to vehicle and component dyads, with favorable safety/tolerability in Phase 2 and Phase 3 studies. In order to examine efficacy and safety of CAB in patients with darker skin phototypes, a post hoc analysis of clinical trial data of participants who self-identified as "Black or African American" was conducted.<h4>Methods</h4>Data were pooled from two Phase 2 and two Phase 3, double-blind, 12-week studies (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.<h4>Results</h4>Of 1,115 participants randomized to CAB or vehicle, 156 (14%) were Black. At Week 12, 32.0 percent of CAB-treated participants achieved treatment success versus 18.3 percent with vehicle (<i>P</i>=0.07). Inflammatory and noninflammatory lesion reductions were significantly greater with CAB versus vehicle (68.8% vs. 51.4% and 57.8% vs. 45.5%, respectively; <i>P</i><0.05, both). TEAE severity was mild to moderate, and hyperpigmentation mean scores remained at/below baseline value (0.7; 1=mild).<h4>Limitations</h4>Studies were not powered to detect significant differences between CAB and vehicle for Black participants; therefore, <i>P</i> values are for informative purposes only.<h4>Conclusion</h4>CAB gel was efficacious and well tolerated in Black participants with acne.