Triple-combination clindamycin phosphate 1.2/benzoyl peroxide 3.1/adapalene 0.15 gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study

摘要

Background/Objectives Topical clindamycin phosphate 1.2/benzoyl peroxide 3.1/adapalene 0.15 gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne.Methods In a randomized, double-blind phase 2 study (NCT03170388), participants >= 9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.Results At Week 12, treatment success rates were significantly greater with IDP-126 (55.8) than with vehicle (5.7; p < .001) or any of the dyad combinations (range: 30.8-33.9; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3 vs. 45.1; noninflammatory: 70.0 vs. 37.6; p < .001, both) and 9.2-16.6 greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity.Conclusion IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne.