Title
Efficacy and safety of a fixed-dose clindamycin phosphate 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
Recommended Citation
Stein Gold L, Kircik LH, Tanghetti, Baldwin H, Draelos Z, Gold M, Lain E, Pariser DM, Sadick N, Pillai R, and Bhatt V. Efficacy and safety of a fixed-dose clindamycin phosphate 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 triplecombination drug. J Clin Aesthet Dermatol 2023; 16(4):S6.
Document Type
Conference Proceeding
Publication Date
3-2023
Publication Title
The Journal of clinical and aesthetic dermatology
Abstract
Background: A three-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 phosphate 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. The efficacy, safety, and tolerability of IDP-126 gel was evaluated in Phase 2 and 3 studies of patients with moderate-to-severe acne.
Methods: A Phase 2 (N=741; NCT03170388) and two Phase 3 (N=183; N=180; NCT04214639; NCT04214652), 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 three 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.
Results: In all three 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<0.01, all). IDP-126 resulted in over 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<0.001, all). Most TEAEs were of mild-moderate severity, and less than 4 percent of IDP-126-treated participants discontinued study/treatment due to AEs.
Conclusion: 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
16
Issue
4
First Page
S6
