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

Pediatr Dermatol. 2023 May-Jun;40(3):452-459. doi: 10.1111/pde.15283. Epub 2023 Mar 22.


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.

Keywords: acne; quality of life; therapy-topical.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

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


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

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