{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,10]],"date-time":"2026-05-10T12:52:56Z","timestamp":1778417576514,"version":"3.51.4"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,4,8]],"date-time":"2022-04-08T00:00:00Z","timestamp":1649376000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100018736","name":"Kaken Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018736","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":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In 2020, 5% sofpironium bromide (ECCLOCK<jats:sup>\u00ae<\/jats:sup>) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at &lt;6\u00a0weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2\u2010week, single\u2010center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged \u226520\u00a0years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2\u2010week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (\u00b1standard deviation [SD]) was 33.3\u00a0\u00b1\u00a09.4\u00a0years. In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05). Mean HDSS scores (\u00b1SD) were significantly decreased from baseline value of 3.5\u00a0\u00b1\u00a00.5 to 2.4\u00a0\u00b1\u00a00.9 on day 7 (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2\u00a0days was 6\u00a0days (95% confidence interval, 4\u20138). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2\u00a0weeks. These results suggest that after 1\u2010week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.<\/jats:p>","DOI":"10.1111\/1346-8138.16384","type":"journal-article","created":{"date-parts":[[2022,4,8]],"date-time":"2022-04-08T11:58:48Z","timestamp":1649419128000},"page":"594-599","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Two\u2010week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis"],"prefix":"10.1111","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0771-3778","authenticated-orcid":false,"given":"Tomoko","family":"Fujimoto","sequence":"first","affiliation":[{"name":"Ikebukuro Nishiguchi Fukurou Dermatology Clinic  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiromichi","family":"Okatsu","sequence":"additional","affiliation":[{"name":"Kaken Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Miyama","sequence":"additional","affiliation":[{"name":"Kaken Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,4,8]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"1379","article-title":"Guidelines of the Japanese dermatological association, clinical guidelines for primary focal hyperhidrosis (revised edition in 2015)","volume":"125","author":"Fujimoto T","year":"2015","journal-title":"Jpn J Dermatol"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.12258"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2014.06.004"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/000486713"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16050"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.15668"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.15927"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.12.029"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4725.2007.33192.x"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.1994.tb01167.x"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.12.040"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.11.066"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/dth.14354"}],"updated-by":[{"DOI":"10.1111\/1346-8138.16511","type":"erratum","label":"Erratum","source":"publisher","updated":{"date-parts":[[2022,7,12]],"date-time":"2022-07-12T00:00:00Z","timestamp":1657584000000}}],"container-title":["The Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.16384","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1346-8138.16384","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.16384","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T04:59:13Z","timestamp":1692853153000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1346-8138.16384"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,8]]},"references-count":13,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["10.1111\/1346-8138.16384"],"URL":"https:\/\/doi.org\/10.1111\/1346-8138.16384","archive":["Portico"],"relation":{"erratum":[{"id-type":"doi","id":"10.1111\/1346-8138.16511","asserted-by":"object"}]},"ISSN":["0385-2407","1346-8138"],"issn-type":[{"value":"0385-2407","type":"print"},{"value":"1346-8138","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,8]]},"assertion":[{"value":"2021-12-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-04-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}