Recommended Citation
Gold LS, Kircik LH, and Tanghetti EA. 32970 Efficacy and safety of a fixed-dose clindamycin 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: Randomized phase 2 and phase 3 studies of the first triple-combination drug. J Am Acad Dermatol 2022; 87(3):AB50.
Document Type
Conference Proceeding
Publication Date
9-1-2022
Publication Title
J Am Acad Dermatol
Abstract
A 3-pronged approach to acne treatment—combining an antibiotic, antibacterial, and retinoid—may provide greater efficacy and tolerability than single/double treatments while potentially reducing antibiotic resistance and increasing patient compliance. Clindamycin 1.2%/BPO 3.1%/adapalene 0.15% (IDP-126) gel is the first triple-combination, fixed-dose topical acne product in development that addresses the major pathophysiological abnormalities in acne patients. A phase 2 (N = 741) and two phase 3 (N = 183; N = 180), double-blind, randomized, 12-week studies enrolled participants aged ≥9 years with moderate-to-severe acne. Participants were randomized to receive once-daily IDP-126 or vehicle; the phase 2 study included 3 additional randomization arms containing dyad gels: BPO/adapalene; clindamycin phosphate/BPO; and clindamycin phosphate/adapalene (data not shown). Endpoints included participants achieving ≥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. In all 3 studies at week 12, half of participants achieved treatment success with IDP-126 (phase 2: 52.5%; phase 3: 49.6%, 50.5%) versus less than one-fourth with vehicle (8.1%; 24.9%, 20.5%; P <.01, all). IDP-126 resulted in >70% reductions in inflammatory and noninflammatory lesions at week 12, significantly greater than vehicle (range: inflammatory, 75.7%-80.1% vs 50.4%-59.6%; noninflammatory, 71.0%-73.3% vs 45.8%-49.0%; P <.001, all). Most TEAEs were of mild-moderate severity, and <4% of IDP-126-treated participants discontinued study/treatment due to AEs. The innovative fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in three clinical studies of children, adolescents, and adults with moderate-to-severe acne.
Volume
87
Issue
3
First Page
AB50
