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

Document Type

Conference Proceeding

Publication Date


Publication Title

The Journal of clinical and aesthetic dermatology


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.





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