{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,14]],"date-time":"2026-02-14T05:39:51Z","timestamp":1771047591361,"version":"3.50.1"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,3,22]],"date-time":"2023-03-22T00:00:00Z","timestamp":1679443200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019507","name":"Ortho Dermatologics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019507","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background\/Objectives<\/jats:title><jats:p>Topical clindamycin phosphate 1.2%\/benzoyl peroxide 3.1%\/adapalene 0.15% gel (IDP\u2010126) is the first fixed\u2010dose triple\u2010combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP\u2010126 in children and adolescents with moderate\u2010to\u2010severe acne.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In a randomized, double\u2010blind phase 2 study (NCT03170388), participants \u22659\u2009years of age with moderate\u2010to\u2010severe acne were eligible for randomization (1:1:1:1:1) to once\u2010daily IDP\u2010126, one of three dyad combination gels, or vehicle gel for 12\u2009weeks. This post hoc analysis of pediatric participants (<jats:italic>n<\/jats:italic>\u00a0=\u00a0394) included children and adolescents up to 17\u2009years of age. Assessments included treatment success, inflammatory\/noninflammatory lesion counts, Acne\u2010Specific Quality of Life (Acne\u2010QoL) questionnaire, treatment\u2010emergent adverse events (TEAEs), and cutaneous safety\/tolerability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At Week 12, treatment success rates were significantly greater with IDP\u2010126 (55.8%) than with vehicle (5.7%; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001) or any of the dyad combinations (range: 30.8%\u201333.9%; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.01, all). Lesion reductions with IDP\u2010126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001, both) and 9.2%\u201316.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne\u2010QoL domain scores were generally greater with IDP\u2010126 than in any other treatment group. The most common treatment\u2010related TEAEs across treatment groups were application site pain and dryness. Most treatment\u2010related TEAEs were of mild\u2010to\u2010moderate severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>IDP\u2010126 gel\u2014a novel fixed\u2010dose, triple\u2010combination topical formulation for acne\u2014demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate\u2010to\u2010severe acne.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pde.15283","type":"journal-article","created":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T04:54:40Z","timestamp":1679547280000},"page":"452-459","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Triple\u2010combination clindamycin phosphate 1.2%\/benzoyl peroxide 3.1%\/adapalene 0.15% gel for moderate\u2010to\u2010severe acne in children and adolescents: Randomized phase 2 study"],"prefix":"10.1111","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2760-0474","authenticated-orcid":false,"given":"Lawrence F.","family":"Eichenfield","sequence":"first","affiliation":[{"name":"Departments of Dermatology and Pediatrics, University of California, San Diego School of Medicine  La Jolla California USA"},{"name":"Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital  San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Stein Gold","sequence":"additional","affiliation":[{"name":"Division of Dermatology, Henry Ford Hospital  Detroit Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leon H.","family":"Kircik","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Icahn School of Medicine at Mount Sinai  New York New York USA"},{"name":"Department of Dermatology, Indiana University Medical Center  Indianapolis Indiana USA"},{"name":"Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC  Louisville Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William P.","family":"Werschler","sequence":"additional","affiliation":[{"name":"Department of Dermatology Elson S. Floyd College of Medicine  Spokane Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth","family":"Beer","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Miami Miller School of Medicine  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zoe D.","family":"Draelos","sequence":"additional","affiliation":[{"name":"Dermatology Consulting Services, PLLC  High Point North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emil A.","family":"Tanghetti","sequence":"additional","affiliation":[{"name":"Center for Dermatology and Laser Surgery  Sacramento California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9557-3642","authenticated-orcid":false,"given":"Kim A.","family":"Papp","sequence":"additional","affiliation":[{"name":"Alliance Clinical Trials and Probity Medical Research  Waterloo Ontario Canada"},{"name":"Division of Dermatology University of Toronto School of Medicine  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hilary","family":"Baldwin","sequence":"additional","affiliation":[{"name":"The Acne Treatment and Research Center  Brooklyn New York USA"},{"name":"Department of Dermatology, Robert Wood Johnson University Hospital  New Brunswick New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Lain","sequence":"additional","affiliation":[{"name":"Austin Institute for Clinical Research  Austin Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neil","family":"Sadick","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Weill Cornell Medical College  New York New York USA"},{"name":"Sadick Dermatology  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melinda J.","family":"Gooderham","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Queens University  Peterborough Ontario Canada"},{"name":"SKiN Centre for Dermatology and Probity Medical Research  Peterborough Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adarsh","family":"Konda","sequence":"additional","affiliation":[{"name":"Ortho Dermatologics (Ortho Dermatologics is a Division of Bausch Health US, LLC)  Bridgewater New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,3,22]]},"reference":[{"issue":"2","key":"e_1_2_8_2_1","first-page":"94","article-title":"Acne vulgaris in the United States: a descriptive epidemiology","volume":"86","author":"Yentzer 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