{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T05:15:11Z","timestamp":1788326111084,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2018,6,15]],"date-time":"2018-06-15T00:00:00Z","timestamp":1529020800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2018,8]]},"abstract":"Abstract<\/jats:title>Adapalene 0.1% (ADA<\/jats:styled-content>) with clindamycin phosphate 1.2% (CLNP<\/jats:styled-content>; ADA<\/jats:styled-content> + CLNP<\/jats:styled-content>) and the fixed\u2010dose combination containing CLNP<\/jats:styled-content> and benzoyl peroxide 3% (CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3%) are strongly recommended for the early treatment of acne vulgaris in Japan. Here, we compare the early efficacy and safety of CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% with Japanese standard topical use of ADA<\/jats:styled-content> + CLNP<\/jats:styled-content> in the treatment of acne vulgaris. In this phase IV<\/jats:styled-content>, multicenter study, 351 patients were randomized to receive CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% or ADA<\/jats:styled-content> + CLNP<\/jats:styled-content> for 12 weeks. The primary end\u2010point was percentage change from baseline in total lesion (TL<\/jats:styled-content>) counts at week 2. Secondary end\u2010points included the percentage change from baseline in TL<\/jats:styled-content>, inflammatory and non\u2010inflammatory lesion (IL<\/jats:styled-content> and non\u2010IL<\/jats:styled-content>) counts, Investigator's Static Global Assessment (ISGA<\/jats:styled-content>), quality of life (QoL [Skindex\u201016]) and patient preference. Local tolerability scores and adverse events were also recorded. CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% provided a significantly greater percentage reduction from baseline in TL<\/jats:styled-content> compared with ADA<\/jats:styled-content> + CLNP<\/jats:styled-content> at week 2, and week 4. Compared with ADA<\/jats:styled-content> + CLNP<\/jats:styled-content>, CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% was superior at reducing IL<\/jats:styled-content> (but not non\u2010IL<\/jats:styled-content>) over weeks 2\u201312, was more effective at improving patient QoL and ISGA<\/jats:styled-content>, and scored higher in patient\u2010preference assessments. Both treatments were well tolerated; adverse drug reactions occurred more frequently in patients receiving ADA<\/jats:styled-content> + CLNP<\/jats:styled-content> (37%) than in those receiving CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% (17%). In conclusion, CLNP<\/jats:styled-content>\/BPO<\/jats:styled-content> 3% showed greater efficacy for the early treatment of acne vulgaris in Japan, with a more favorable safety profile compared with ADA<\/jats:styled-content> + CLNP<\/jats:styled-content>.<\/jats:p>","DOI":"10.1111\/1346-8138.14497","type":"journal-article","created":{"date-parts":[[2018,6,15]],"date-time":"2018-06-15T10:08:31Z","timestamp":1529057311000},"page":"951-962","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Clindamycin phosphate 1.2%\/benzoyl peroxide 3% fixed\u2010dose combination gel versus topical combination therapy of adapalene 0.1% gel and clindamycin phosphate 1.2% gel in the treatment of acne vulgaris in Japanese patients: A multicenter, randomized, investigator\u2010blind, parallel\u2010group study"],"prefix":"10.1111","volume":"45","author":[{"given":"Nobukazu","family":"Hayashi","sequence":"first","affiliation":[{"name":"Department of Dermatology Toranomon Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1440-5178","authenticated-orcid":false,"given":"Ichiro","family":"Kurokawa","sequence":"additional","affiliation":[{"name":"Department of Dermatology Acne Clinical Research Center Meiwa Hospital Nishinomiya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Obukohwo","family":"Siakpere","sequence":"additional","affiliation":[{"name":"Medical Affairs, R&D Chief Medical Office Stiefel Medical GSK London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Endo","sequence":"additional","affiliation":[{"name":"Biomedical Data Sciences Department Japan Development and Medical Affairs GlaxoSmithKline KK Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiki","family":"Hatanaka","sequence":"additional","affiliation":[{"name":"Medical Affairs Japan Development and Medical Affairs GlaxoSmithKline KK Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7370-2463","authenticated-orcid":false,"given":"Masahiro","family":"Yamada","sequence":"additional","affiliation":[{"name":"Medical Affairs Japan Development and Medical Affairs GlaxoSmithKline KK Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Kawashima","sequence":"additional","affiliation":[{"name":"Department of Dermatology Tokyo Women's Medical University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,6,15]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13462"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13182"},{"issue":"10","key":"e_1_2_7_4_1","first-page":"1893","article-title":"Guideline for the treatment of acne vulgaris. (in Japanese)","volume":"118","author":"Hayashi N","year":"2008","journal-title":"Jpn J Dermatol"},{"issue":"126","key":"e_1_2_7_5_1","first-page":"1045","article-title":"Guideline for the treatment of acne vulgaris (in Japanese)","volume":"2016","author":"Hayashi N","year":"2016","journal-title":"Jpn J Dermatol"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13265"},{"key":"e_1_2_7_7_1","unstructured":"FDA FADA.FDA Guidance for Industry: Acne Vulgaris \u2013 Developing Drugs for Treatment(Draft)2005."},{"key":"e_1_2_7_8_1","first-page":"1382","article-title":"Safety and efficacy of clindamycin phosphate 1.2%\u2010benzoyl peroxide 3% fixed\u2010dose combination gel for the treatment of acne vulgaris: A phase 3, multicenter, randomized, double\u2010blind, active\u2010 and vehicle\u2010controlled study","volume":"10","author":"Eichenfield LF","year":"2011","journal-title":"J Drugs Dermatol"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/120347540100500202"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1346-8138.2002.tb00205.x"},{"issue":"9","key":"e_1_2_7_11_1","first-page":"1033","article-title":"The efficacy, safety and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; 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