Impact of Age or Sex on Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel in Participants with Moderate-to-Severe Acne

Abstract

Introduction: IDP-126 (clindamycin phosphate 1.2%/benzoyl peroxide [BPO] 3.1%/adapalene 0.15%) polymeric mesh gel is the first triple-combination, fixed-dose topical acne treatment in development. IDP-126 demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability, in a phase 2 and two phase 3 studies of participants with moderate-to-severe acne. The objective of this analysis was to assess the impact of age or sex on efficacy and safety/tolerability of IDP-126 gel. Methods: This post hoc analysis evaluated effect of age or sex on efficacy/safety of IDP-126 using data pooled from two phase 3, double-blind, randomized, 12-week studies (NCT04214639, N=183; NCT04214652, N=180). Participants aged ≥9 years with moderate-to-severe acne were randomized 2:1 to once-daily IDP-126 gel or vehicle gel. Data were analyzed by age (pediatric [9-17 years]: n=178; adult [≥18 years]: n=185) or sex (females: n=212; males: n=151). 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 and noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were also assessed. Results: At week 12, over half of pediatric and almost half of adult IDP-126-treated participants achieved treatment success (52.7% and 45.9%, respectively) versus one-fourth with vehicle (24.0% and 23.5%; P<0.01, both). Results by sex were similar (IDP‑126 vs vehicle: females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). IDP‑126 provided >70% reductions in inflammatory and noninflammatory lesions in all subgroups, versus 41%-63% with vehicle (P≤0.001, all). Differences between sex or age groups were not statistically significant. Most TEAEs were of mild-moderate severity in all groups. Conclusions: Fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age or sex, with approximately half of participants achieving clear/almost clear skin. Funding: Ortho Dermatologics