{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T14:24:02Z","timestamp":1792506242983,"version":"4.5.0"},"reference-count":21,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,1,7]],"date-time":"2021-01-07T00:00:00Z","timestamp":1609977600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI\u20104000) gel (hereinafter referred to as sofpironium) administrated for 6\u00a0weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end\u2010point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6\u2010week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0\u00a0years. The proportion of patients who achieved the primary efficacy end\u2010point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02\u201328.93) between these two groups (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, \u22655%) were nasopharyngitis (14.2%) and dermatitis\/erythema at the application site (8.5%\/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.<\/jats:p>","DOI":"10.1111\/1346-8138.15668","type":"journal-article","created":{"date-parts":[[2021,1,10]],"date-time":"2021-01-10T14:08:07Z","timestamp":1610287687000},"page":"279-288","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["A phase 3, multicenter, randomized, double\u2010blind, vehicle\u2010controlled, parallel\u2010group study of 5% sofpironium bromide (BBI\u20104000) gel in Japanese patients with primary axillary hyperhidrosis"],"prefix":"10.1111","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5773-9485","authenticated-orcid":false,"given":"Hiroo","family":"Yokozeki","sequence":"first","affiliation":[{"name":"Department of Dermatology Tokyo Medical and Dental University Tokyo 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