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

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