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

Abstract

Background: Triple-combination therapies for acne including an antibiotic, topical retinoid, and benzoyl peroxide (BPO) are more effective than dual combinations or topical monotherapy. In clinical studies of participants with moderate to severe acne, clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/BPO 3.1% (CAB) gel demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Because acne pathogenesis and presentation can vary by skin type and ethnicity, it is important to assess treatment outcomes for specific populations. This post hoc analysis assessed efficacy and safety of CAB gel in Caucasian participants.

Methods: Data were pooled from two phase 2 and two phase 3 double-blind, 12-week studies of participants with moderate to severe acne (N=1787). The pooled population included 1283 self-identified Caucasian participants, randomized to 6 treatment arms: once-daily CAB gel (n=446), ADAP 0.15%/BPO 3.1% gel (n=109), CLIN 1.2%/BPO 3.1% gel (n=101), CLIN 1.2%/ADAP 0.15% gel (n=109), branded ADAP 0.3%/BPO 2.5% gel (n=165), and vehicle (n=353). Endpoints included treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]) and reductions from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed.

Results: At week 12, a significantly greater percentage of Caucasian participants achieved treatment success with CAB gel (51.5%) than dyads (range, 31.7%-34.3%), randed ADAP 0.3%/BPO 2.5% gel (33.5%), or vehicle (17.9%; P<0.01, all). CAB yielded significantly greater reductions from baseline in inflammatory and noninflammatory lesions (76.8% and 73.0%, respectively) than dyads (62.7%-70.2% and 60.9%-63.4%, P<0.01, all), randed ADAP 0.3%/BPO 2.5% gel (72.6% and 65.7%, P<0.05, both) and vehicle (52.3% and 44.8%, P<0.001, both). Most TEAEs were of mild to moderate severity; the most common treatment-related TEAEs were application site pain, dryness, dermatitis, and erythema. Transient increases in cutaneous safety/tolerability scores beginning at week 2 resolved back to or near baseline by week 12; all scores were <1 (mild) at all post-baseline assessments.

Conclusions: In Caucasian participants with moderate to severe acne across 4 clinical studies, triple-combination CAB gel demonstrated significantly greater efficacy without worsening tolerability vs dyad gels, randed ADAP 0.3%/BPO 2.5% gel, or vehicle.

Funding: Ortho Dermatologics