{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T14:43:30Z","timestamp":1774449810804,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2014,8,11]],"date-time":"2014-08-11T00:00:00Z","timestamp":1407715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Stiefel"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2014,9]]},"abstract":"Abstract<\/jats:title>Benzoyl peroxide (BPO<\/jats:styled-content>) as an anti\u2010acne medication is not yet approved in J<\/jats:styled-content>apan. This study evaluated the efficacy and safety of a once\u2010daily topical application of BPO<\/jats:styled-content> 3% gel versus an inert vehicle gel in J<\/jats:styled-content>apanese acne patients. Three hundred and sixty patients were randomized to receive BPO<\/jats:styled-content> 3% or vehicle for 12\u00a0weeks. The primary efficacy end\u2010point was absolute change in number of total lesions (TL<\/jats:styled-content>) from baseline to week 12 to demonstrate the superiority of BPO<\/jats:styled-content> 3% versus vehicle. Secondary efficacy end\u2010points were absolute and percent change in TL<\/jats:styled-content>, inflammatory lesions (IL<\/jats:styled-content>), non\u2010inflammatory lesions (non\u2010IL<\/jats:styled-content>) and I<\/jats:styled-content>nvestigator's S<\/jats:styled-content>tatic G<\/jats:styled-content>lobal A<\/jats:styled-content>ssessment (ISGA<\/jats:styled-content>). Change in TL<\/jats:styled-content> counts from baseline to week 12 for BPO<\/jats:styled-content> 3% was superior to vehicle (difference, \u221221.0; P\u00a0<\/jats:italic><\u00a0<\/jats:italic>0.001). Absolute and percent reductions in TL<\/jats:styled-content>, IL<\/jats:styled-content> and non\u2010IL<\/jats:styled-content> counts were greater for BPO<\/jats:styled-content> 3% at all study visits. The proportion of patients with improvement in ISGA<\/jats:styled-content> scores was significantly higher with BPO<\/jats:styled-content> 3% than with vehicle from week 2. All adverse events were mild or moderate. Adverse drug\u2010related reactions were higher for BPO<\/jats:styled-content> 3% (30%) than with vehicle (5%). Local tolerability scores of grade 1 or more (slight to moderate) were more frequent with BPO<\/jats:styled-content> 3% than vehicle with the most significant differences observed in dryness (56% vs 27% at week 1\u20134), peeling (19% vs 9% at week 1\u20132) and burning\/stinging (58% vs 15% at week 1\u201312). These results indicate that BPO<\/jats:styled-content> 3% is effective while maintaining a favorable safety and tolerability profile in J<\/jats:styled-content>apanese acne patients.<\/jats:p>","DOI":"10.1111\/1346-8138.12580","type":"journal-article","created":{"date-parts":[[2014,8,11]],"date-time":"2014-08-11T09:52:30Z","timestamp":1407750750000},"page":"795-801","source":"Crossref","is-referenced-by-count":16,"title":["Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in J<\/scp>apanese patients? A multicenter, randomized, double\u2010blind, vehicle\u2010controlled, parallel\u2010group study"],"prefix":"10.1111","volume":"41","author":[{"given":"Makoto","family":"Kawashima","sequence":"first","affiliation":[{"name":"Department of Dermatology Tokyo Women's Medical University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirofumi","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Biomedical Data Science Japan Development and Medical Affairs GlaxoSmithKline K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra B.","family":"Alio S\u00e1enz","sequence":"additional","affiliation":[{"name":"Medicines Development R&D Stiefel a GSK company Research Triangle Park North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Ono","sequence":"additional","affiliation":[{"name":"Business Innovation GlaxoSmithKline K.K. 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