{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:04:47Z","timestamp":1775779487576,"version":"3.50.1"},"reference-count":16,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,2,24]],"date-time":"2016-02-24T00:00:00Z","timestamp":1456272000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Stiefel, a GSK company","award":["GSK200398"],"award-info":[{"award-number":["GSK200398"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Mild\u2010to\u2010moderate acne vulgaris is treated with a range of mono\u2010 and combination therapies; however, clinical evidence is still required to optimize treatment recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To compare the efficacy, tolerability and safety of a combination of benzoyl peroxide 3% and clindamycin 1% (<jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content>) with azelaic acid 20% (AzA) for the topical treatment of mild\u2010to\u2010moderate acne vulgaris.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>This was a randomized, assessor\u2010blinded, parallel\u2010group, multicentre study conducted in Germany. Patients with a confirmed diagnosis of acne vulgaris, aged 12\u201345 years, were randomized 1 : 1 to once\u2010daily <jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content> gel or twice\u2010daily AzA cream for up to 12 weeks. The primary endpoint was the percentage change in inflammatory lesions from baseline at Week 4. Secondary endpoints included total and inflammatory lesion counts and tolerability assessments. For selected secondary endpoints, inductive statistical analysis was performed post hoc. Patient safety was assessed by adverse event (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>) monitoring.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Efficacy was assessed in the modified intent\u2010to\u2010treat (mITT) population [patients using \u22651 dose of study medication (<jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content>), plus baseline and \u22651 post\u2010baseline lesion count (<jats:italic>n<\/jats:italic> = 215)]. There was a statistically significant difference in the primary endpoint, with a median decrease of \u221252.6% for <jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content> (<jats:italic>n<\/jats:italic> = 107) vs.\u221238.8% for AzA (<jats:italic>n<\/jats:italic> = 108; <jats:italic>P<\/jats:italic> = 0.0004). There was also a greater difference in secondary lesion endpoints at Week 12, with a median decrease in inflammatory lesions of \u221278.8% and \u221265.3% and total lesions of \u221269.0% and \u221253.9% with <jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content> and AzA, respectively (both <jats:italic>P<\/jats:italic> &lt; 0.0001). Tolerability was acceptable for both treatments. Overall, 55.6% (<jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content>) and 69.7% (AzA) of patients reported treatment\u2010emergent <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, and 15.7% and 35.8% of patients experienced application site reactions with <jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content> (24 events; 17 patients) and AzA (60 events; 39 patients) treatment, respectively (<jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content> population).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">BPO<\/jats:styled-content> + <jats:styled-content style=\"fixed-case\">CLN<\/jats:styled-content> demonstrated greater efficacy than AzA in the treatment of mild\u2010to\u2010moderate acne vulgaris and has a positive tolerability and safety profile.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.13541","type":"journal-article","created":{"date-parts":[[2016,2,26]],"date-time":"2016-02-26T07:53:19Z","timestamp":1456473199000},"page":"966-973","source":"Crossref","is-referenced-by-count":26,"title":["A multicentre, randomized, single\u2010blind, parallel\u2010group study comparing the efficacy and tolerability of benzoyl peroxide 3%\/clindamycin 1% with azelaic acid 20% in the topical treatment of mild\u2010to\u2010moderate acne vulgaris"],"prefix":"10.1111","volume":"30","author":[{"given":"M.","family":"Schaller","sequence":"first","affiliation":[{"name":"Department of Dermatology University of T\u00fcbingen T\u00fcbingen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Sebastian","sequence":"additional","affiliation":[{"name":"Hautarztpraxis Mahlow, Mahlow Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Ress","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Germany Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D.","family":"Seidel","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Germany Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Hennig","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Germany Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,2,24]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"crossref","first-page":"8","DOI":"10.5070\/D30T2870V9","article-title":"Acne vulgaris: more than skin deep","volume":"9","author":"Hanna S","year":"2003","journal-title":"Dermatol Online J"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2009.47"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2011.04374.x"},{"key":"e_1_2_7_5_1","unstructured":"Stiefel.Duac\u00aeonce daily 10 mg\/g + 30 mg\/g gel: summary of product characteristics. 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