Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
brief summary
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score \[EGSS\] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
official title
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris