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

• DOI: 10.1111/pde.15283
• Publication Date: 2023-03-23T04:54:40Z
• Authors: Lawrence F. Eiche...; 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
• Keywords: Adolescent; Benzoyl Peroxide; Clindamycin; Infant, Newborn; Severity of Illness Index; 3. Good health; Peroxides; Drug Combinations; Treatment Outcome; Double-Blind Method; Acne Vulgaris; Quality of Life; Humans; Dermatologic Agents; Adapalene; Child; Gels

AbstractBackground/ObjectivesTopical 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.MethodsIn 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.ResultsAt 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.ConclusionIDP‐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.