Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis

Abstract

Background: A three-pronged approach to acne treatment that combines an antibiotic, antimicrobial agent, and retinoid in a single formulation may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. IDP-126 polymeric mesh gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide [BPO] 3.1%)—the first fixed-dose triple-combination acne topical in development—demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability in a phase 2 and two phase 3 studies of moderate-to-severe acne. This post hoc analysis further examined efficacy and safety of IDP-126 in data pooled from these phase 3 studies.

Methods: In two identical phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily IDP-126 or vehicle gel. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated.

Results: A total of 363 participants were randomized; a majority were female (58.4%) and had moderate acne (91.2%). At week 12, 50.0% of participants achieved treatment success with IDP-126 versus 22.6% with vehicle gel (P<0.001). IDP-126 resulted in over 70% reductions in inflammatory and noninflammatory lesions at week 12, which were significantly greater than vehicle (inflammatory: 77.9% vs 57.9%, respectively; noninflammatory: 73.0% vs 48.2%; P<0.001, both). Most TEAEs were of mild-moderate severity, and <3% of IDP-126-treated participants discontinued study/treatment due to AEs. Transient increases from baseline in investigator-assessed scaling and erythema and participant-assessed itching, burning, and stinging were observed with IDP-126, but resolved back to or near baseline values by week 12.

Conclusions: The innovative fixed-dose triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear or almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.

Funding: Ortho Dermatologics