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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 |
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| Authors: | Lawrence F. Eichenfield MD Linda Stein Gold MD Leon H. Kircik MD William P. Werschler MD Kenneth Beer MD Zoe D. Draelos MD Emil A. Tanghetti MD Kim A. Papp MD PhD Hilary Baldwin MD Edward Lain MD MBA Neil Sadick MD Melinda J. Gooderham MSc MD Adarsh Konda Pharm.D. |
| Affiliation: | 1. Departments of Dermatology and Pediatrics, University of California, San Diego School of Medicine, La Jolla, California, USA;2. Division of Dermatology, Henry Ford Hospital, Detroit, Michigan, USA;3. Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA Department of Dermatology, Indiana University Medical Center, Indianapolis, Indiana, USA Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, Kentucky, USA;4. Department of Dermatology, Elson S. Floyd College of Medicine, Spokane, Washington, USA;5. Department of Dermatology, University of Miami Miller School of Medicine, Miami, Florida, USA;6. Dermatology Consulting Services, PLLC, High Point, North Carolina, USA;7. Center for Dermatology and Laser Surgery, Sacramento, California, USA;8. Alliance Clinical Trials and Probity Medical Research, Waterloo, Ontario, Canada;9. The Acne Treatment and Research Center, Brooklyn, New York, USA Department of Dermatology, Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA;10. Austin Institute for Clinical Research, Austin, Texas, USA;11. Department of Dermatology, Weill Cornell Medical College, New York, New York, USA Sadick Dermatology, New York, New York, USA;12. Department of Dermatology, Queens University, Peterborough, Ontario, Canada SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada;13. Ortho Dermatologics (Ortho Dermatologics is a Division of Bausch Health US, LLC), Bridgewater, New Jersey, USA |
| Abstract: | Background/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. |
| Keywords: | acne quality of life therapy—topical |