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.

Abstract

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.

• Authors: Lawrence F Eichenfield, Linda Stein Gold, Leon H Kircik, William P Werschler, Kenneth Beer, Zoe D Draelos, Emil A Tanghetti, Kim A Papp, Hilary Baldwin, Edward Lain, Neil Sadick, Melinda J Gooderham, Adarsh Konda
• Journal: Pediatric dermatology (Pediatr Dermatol) 2023 May-Jun Vol. 40 Issue 3 Pg. 452-459 ISSN: 1525-1470 [Electronic] United States
• PMID: 36949579 (Publication Type: Clinical Trial, Phase II, Randomized Controlled Trial, Journal Article)
• Copyright: © 2023 The Authors. Pediatric Dermatology published by Wiley Periodicals LLC.

Chemical References

• Adapalene
• Dermatologic Agents
• clindamycin phosphate
• Benzoyl Peroxide
• Peroxides
• Drug Combinations
• Clindamycin
• Gels

Topics

• Humans
• Child
• Adolescent
• Infant, Newborn
• Adapalene (therapeutic use)
• Dermatologic Agents (adverse effects)
• Benzoyl Peroxide (adverse effects)
• Quality of Life
• Peroxides (therapeutic use)
• Drug Combinations
• Severity of Illness Index
• Acne Vulgaris (drug therapy)
• Clindamycin (adverse effects)
• Treatment Outcome
• Gels (therapeutic use)
• Double-Blind Method