Early acne improvements with fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel: What to expect in the first 4 weeks of treatment

Document Type

Conference Proceeding

Publication Date

11-12-2025

Publication Title

J Clin Aesthet Dermatol

Abstract

Introduction: Treatments with fast and substantial acne clearance are highly desirable. While a three-pronged approach can increase treatment efficacy versus monotherapy or dual-combination therapy, it is unknown if triple-combination provides more rapid improvement. CAB gel—clindamycin phosphate (clin) 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1%—is the first fixed-dose, triple-combination acne topical. Since rapid/substantial acne improvements and fewer side effects can increase adherence, the efficacy and safety of CAB in the first four weeks of treatment was evaluated. Methods: In a Phase 2 (N=741; NCT03170388) and two Phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel; the Phase 2 study included three additional dyad arms: BPO/adapalene; clin/BPO; and clin/adapalene. Efficacy assessments included least-squares mean percent change from baseline in inflammatory and noninflammatory lesions. Cutaneous safety/tolerability assessments were graded from 0=none to 3=severe. Post-hoc analyses included percentages of participants with one-third and one-half acne lesion reductions. Results: At Week 4, CAB led to approximately 55 percent reductions from baseline in inflammatory acne lesions in the ph2 and pooled ph3 studies, significantly greater than vehicle (~40%) and its three dyads (ph2 range: 44.2-47.6%; p<0.05, all). The percentages of participants with one-third and one-half reductions of inflammatory lesions were significantly greater with CAB than vehicle and dyads (p<0.05, all). Similar trends were observed for noninflammatory lesions, though reductions were less pronounced. As expected for retinoids, transient increases from baseline to Week 2 in scaling, erythema, itching, burning, and stinging were observed for CAB, BPO/adapalene, and clin/adapalene, with mean scores ≤ 0.6 (1=mild); no trends in dyspigmentation were observed. Mean scores for all cutaneous assessments were highest for BPO/adapalene, indicating that adding a third product in the fixed-dose CAB gel formulation did not worsen tolerability. Conclusion: Acne lesion reductions were significantly greater with clin 1.2%/adapalene 0.15%/BPO 3.1% gel versus its dyads and vehicle gel as early as Week 4. More rapid efficacy with this first fixed-dose triple-combination acne product—coupled with its optimized formulation, once-daily dosing, and tolerability—might positively impact treatment adherence.

Volume

18

Issue

Suppl 1

First Page

S36

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