{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:24:50Z","timestamp":1789604690140,"version":"build-2803163510"},"reference-count":17,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,3,8]],"date-time":"2020-03-08T00:00:00Z","timestamp":1583625600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013988","name":"Dermira","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013988","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background\/Objectives<\/jats:title><jats:p>Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients \u22659\u00a0years. This post hoc analysis evaluated long\u2010term response (efficacy and safety) in pediatric patients (\u22659 to \u226416\u00a0years) to GT in the 44\u2010week, open\u2010label extension (NCT02553798) of two, phase 3, double\u2010blind, vehicle\u2010controlled, 4\u2010week trials (NCT02530281, NCT02530294).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In the double\u2010blind trials, patients \u22659\u00a0years with primary axillary hyperhidrosis were randomized 2:1 to once\u2010daily GT:vehicle. Those who completed the study could receive open\u2010label GT for up to an additional 44\u00a0weeks. Safety assessments included treatment\u2010emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (\u22652\u2010grade improvement), and Children's Dermatology Life Quality Index.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 43 pediatric patients completing either double\u2010blind trial, 38 (88.4%) entered the open\u2010label extension (age, years: 9 [n\u00a0=\u00a01], 12 [n\u00a0=\u00a02], 13 [n\u00a0=\u00a07], 14 and 15 [n\u00a0=\u00a09 each], 16\u00a0[n\u00a0=\u00a010]). The safety profile observed was similar to the double\u2010blind trials. Most TEAEs (&gt;95%) were mild\/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n\u00a0=\u00a01\/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7\u00a0days. Approximately, one\u2010third of patients (n\u00a0=\u00a013\/38 [34.2%]) had LSRs; most were mild\/moderate in severity. Improvements in efficacy measures were maintained from the double\u2010blind trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Long\u2010term, once\u2010daily GT for up to 48\u00a0weeks (4\u2010week double\u2010blind plus 44\u00a0week open label) provides a noninvasive, well\u2010tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pde.14135","type":"journal-article","created":{"date-parts":[[2020,3,9]],"date-time":"2020-03-09T01:59:36Z","timestamp":1583719176000},"page":"490-497","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Long\u2010term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44\u2010week open\u2010label extension study"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9167-5729","authenticated-orcid":false,"given":"Adelaide A.","family":"Hebert","sequence":"first","affiliation":[{"name":"UTHealth McGovern Medical School Houston Texas United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dee Anna","family":"Glaser","sequence":"additional","affiliation":[{"name":"Saint Louis University St. Louis Missouri United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Green","sequence":"additional","affiliation":[{"name":"George Washington University School of Medicine Washington District of Columbia United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Hull","sequence":"additional","affiliation":[{"name":"Northwest Arkansas Clinical Trials Center PLLC Rogers Arkansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Cather","sequence":"additional","affiliation":[{"name":"Modern Research Associates PLLC Dallas Texas United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Drew","sequence":"additional","affiliation":[{"name":"Dermira, Inc. Menlo Park California United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramanan","family":"Gopalan","sequence":"additional","affiliation":[{"name":"Dermira, Inc. Menlo Park California United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Pariser","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School Virginia Clinical Research, Inc. Norfolk Virginia United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,3,8]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00403-016-1697-9"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-016-0148-z"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.12.040"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-2755"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2014.06.005"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1098-3015(10)63957-5"},{"key":"e_1_2_7_8_1","unstructured":"QBREXZA\u00ae (glycopyrronium) cloth [prescribing information].Dermira Inc Menlo Park CA;2018."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.07.002"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/pde.13723"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-019-00446-6"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-019-0148-8"},{"key":"e_1_2_7_13_1","first-page":"S16","article-title":"Confirmatory psychometric evaluation of the Axillary Sweating Daily Diary: a validated patient\u2010reported outcome measure to assess axillary hyperhidrosis symptom severity [abstract]","author":"Glaser D","year":"2018","journal-title":"J Clin Aesthet Dermatol"},{"issue":"8","key":"e_1_2_7_14_1","first-page":"908","article-title":"A comprehensive approach to the recognition, diagnosis, and severity\u2010based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee","volume":"33","author":"Solish N","year":"2007","journal-title":"Dermatol Surg"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-018-0395-0"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.1994.tb01167.x"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.1995.tb16953.x"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0846.2007.00282.x"}],"container-title":["Pediatric Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.14135","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/pde.14135","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.14135","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T07:56:05Z","timestamp":1693986965000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pde.14135"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,8]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["10.1111\/pde.14135"],"URL":"https:\/\/doi.org\/10.1111\/pde.14135","archive":["Portico"],"relation":{},"ISSN":["0736-8046","1525-1470"],"issn-type":[{"value":"0736-8046","type":"print"},{"value":"1525-1470","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,8]]},"assertion":[{"value":"2019-12-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-02-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}