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

Skinmed. 2024 Oct 22;22(5):375-378. eCollection 2024.

Abstract

CabtreoTM (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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris* / drug therapy
  • Adapalene / administration & dosage
  • Adapalene / therapeutic use
  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Benzoyl Peroxide / administration & dosage
  • Benzoyl Peroxide / therapeutic use
  • Clindamycin* / administration & dosage
  • Clindamycin* / therapeutic use
  • Dermatologic Agents* / administration & dosage
  • Dermatologic Agents* / therapeutic use
  • Drug Combinations*
  • Female
  • Gels*
  • Humans
  • Male

Substances

  • Clindamycin
  • Gels
  • Dermatologic Agents
  • Drug Combinations
  • Benzoyl Peroxide
  • clindamycin phosphate benzoyl peroxide combination
  • Adapalene