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: A Randomized Phase II Study of the First Triple-Combination Drug

Abstract

Background A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. Objectives We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. Methods In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. Results A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. Conclusions Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/ adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. Clinical Trial Registration ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).

Acne treatment review and future perspectives

“…76 Participants randomized to the IDP-126 cohort had significantly greater absolute mean reductions in inflammatory and noninflammatory lesions from baseline to week 12 as compared to the other cohorts. 76 Also, 52.5% of the participants in the IDP-126 cohort attained treatment success at week 12, which is significantly greater than the vehicle gel cohort (8.1%, p < 0.001) and the three dyad gels (range 27.8%-30.5%; p ≤ 0.001). 76 Despite promising research results on new therapeutic combinations, the cost-effectiveness of such treatments needs to be carefully considered by the clinician and weighed against the potential benefits.…”

“…75 A multicenter, randomized, double-blind, 12 week, phase 3 study evaluated the efficacy of a fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel (IDP-126 gel, NCT04214639). 76 This formulation is the first triple-combination drug to be developed and tested in the treatment of acne vulgaris and once daily for 12 weeks. 76 Participants randomized to the IDP-126 cohort had significantly greater absolute mean reductions in inflammatory and noninflammatory lesions from baseline to week 12 as compared to the other cohorts.…”

“…76 This formulation is the first triple-combination drug to be developed and tested in the treatment of acne vulgaris and once daily for 12 weeks. 76 Participants randomized to the IDP-126 cohort had significantly greater absolute mean reductions in inflammatory and noninflammatory lesions from baseline to week 12 as compared to the other cohorts. 76 Also, 52.5% of the participants in the IDP-126 cohort attained treatment success at week 12, which is significantly greater than the vehicle gel cohort (8.1%, p < 0.001) and the three dyad gels (range 27.8%-30.5%; p ≤ 0.001).…”

“…A multicenter, randomized, double‐blind, 12 week, phase 3 study evaluated the efficacy of a fixed‐dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel (IDP‐126 gel, NCT04214639) 76 . This formulation is the first triple‐combination drug to be developed and tested in the treatment of acne vulgaris and shows promising results.…”

“…This formulation is the first triple‐combination drug to be developed and tested in the treatment of acne vulgaris and shows promising results. Participants were randomized to receive either IDP‐126 ( n = 147), vehicle gel ( n = 148), or one of the three component dyads (benzoyl peroxide/adapalene ( n = 150), clindamycin/benzoyl peroxide ( n = 146), or clindamycin/adapalene ( n = 150)) once daily for 12 weeks 76 . Participants randomized to the IDP‐126 cohort had significantly greater absolute mean reductions in inflammatory and noninflammatory lesions from baseline to week 12 as compared to the other cohorts 76 .…”