CABTREOTM (Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide) Topical Gel.

Abstract

Cabtreo^TM (1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide) or IDP-126 topical gel was approved by the US Food and Drug Administration (FDA) in October 2023 for the treatment of moderate to severe acne vulgaris in patients aged ≥12 years. Its effectiveness and safety were evaluated in two phase 3 trials (Trial 1 and Trial 2). In both trials, subjects were randomized into two groups, one received IDP-126 gel and the other received vehicle gel. The primary efficacy end point was treatment success at week 12, defined as subjects achieving at least a 2-grade reduction from baseline in Evaluator's Global Severity Score (EGGS) and a final score ranging from 0 (clear) to 1 (almost clear) as well as reduced counts of inflammatory and non-inflammatory lesions. In Trial 1 (N = 183), treatment success was achieved in 49.6% (61/122) of subjects in the IDP-126 group versus 24.9% (15/61) of subjects in the vehicle group (P < 0.01). In Trial 2 (N = 180), treatment success was achieved in 50.5% (61/120) of subjects in the IDP-126 group versus 20.5% (12/60) of subjects in the vehicle group (P < 0.01). IDP-126 is therefore recommended to be applied as a thin layer to the affected area once daily.