{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T18:55:27Z","timestamp":1789844127167,"version":"4.0.1"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,11,19]],"date-time":"2018-11-19T00:00:00Z","timestamp":1542585600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Dermira, Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle\u2010controlled, 4\u2010week trials (\n                      <jats:styled-content style=\"fixed-case\">ATMOS<\/jats:styled-content>\n                      \u20101 [\n                      <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n                      02530281] and\n                      <jats:styled-content style=\"fixed-case\">ATMOS<\/jats:styled-content>\n                      \u20102 [\n                      <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n                      02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      ) in pediatric patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients had primary axillary hyperhidrosis\u00a0\u2265\u00a06\u00a0months, average Axillary Sweating Daily Diary (\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \/\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \u2010Children [\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \u2010C]) Item 2 (sweating severity) score\u00a0\u2265\u00a04, sweat production \u2265\u00a050\u00a0mg\/5\u00a0min (each axilla), and Hyperhidrosis Disease Severity Scale (\n                      <jats:styled-content style=\"fixed-case\">HDSS<\/jats:styled-content>\n                      )\u00a0\u2265\u00a03. Coprimary end points were \u2265\u00a04\u2010point improvement on\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \/\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \u2010C Item 2 (a validated patient\u2010reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (\u2265\u00a09 to \u2264\u00a016\u00a0years) vs older (&gt;\u00a016\u00a0years) subgroups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Six hundred and ninety\u2010seven patients were randomized in\n                      <jats:styled-content style=\"fixed-case\">ATMOS<\/jats:styled-content>\n                      \u20101\/\n                      <jats:styled-content style=\"fixed-case\">ATMOS<\/jats:styled-content>\n                      \u20102 (\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      , N\u00a0=\u00a0463; vehicle, N\u00a0=\u00a0234); 44 were \u2265\u00a09 to \u2264\u00a016\u00a0years (\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      , n\u00a0=\u00a025; vehicle, n\u00a0=\u00a019). Baseline disease characteristics were generally similar across subgroups.\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      \u2010treated pediatric vs older patients had comparable improvements in\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \/\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \u2010C Item 2 (sweating severity) responder rate,\n                      <jats:styled-content style=\"fixed-case\">HDSS<\/jats:styled-content>\n                      responder rate (\u2265\u00a02\u2010grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [\n                      <jats:styled-content style=\"fixed-case\">DLQI<\/jats:styled-content>\n                      ]\/children's\n                      <jats:styled-content style=\"fixed-case\">DLQI<\/jats:styled-content>\n                      ), with greater improvement vs vehicle. Treatment\u2010emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Topical, once\u2010daily\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      improved disease severity (\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \/\n                      <jats:styled-content style=\"fixed-case\">ASDD<\/jats:styled-content>\n                      \u2010C,\n                      <jats:styled-content style=\"fixed-case\">HDSS<\/jats:styled-content>\n                      ), sweat production, and quality of life (\n                      <jats:styled-content style=\"fixed-case\">DLQI<\/jats:styled-content>\n                      ), with similar findings in children, adults, and the pooled population.\n                      <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>\n                      was well tolerated, and treatment\u2010emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pde.13723","type":"journal-article","created":{"date-parts":[[2018,11,19]],"date-time":"2018-11-19T09:51:12Z","timestamp":1542621072000},"page":"89-99","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials"],"prefix":"10.1111","volume":"36","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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dee Anna","family":"Glaser","sequence":"additional","affiliation":[{"name":"Saint Louis University St. Louis Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Green","sequence":"additional","affiliation":[{"name":"George Washington University School of Medicine Washington District of Columbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William P.","family":"Werschler","sequence":"additional","affiliation":[{"name":"Premier Clinical Research Spokane Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglass W.","family":"Forsha","sequence":"additional","affiliation":[{"name":"Jordan Valley Dermatology and Research Center West Jordan Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Drew","sequence":"additional","affiliation":[{"name":"Dermira, Inc. Menlo Park California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramanan","family":"Gopalan","sequence":"additional","affiliation":[{"name":"Dermira, Inc. Menlo Park California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Pariser","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School and Virginia Clinical Research, Inc. Norfolk Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,19]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00403-016-1697-9"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-016-0148-z"},{"key":"e_1_2_8_4_1","unstructured":"HebertA GlaserDA BallardA PierettiL deTrindade AlmeidaA PariserD.Prevalence of primary focal hyperhidrosis (PFHh) among teens 12\u201017 in U.S. Population. Oral (Late\u2010Breaker) presented at 75th Annual Meeting of the American Academy of Dermatology;2017;Orlando FL."},{"issue":"1","key":"e_1_2_8_5_1","first-page":"25","article-title":"Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results","volume":"37","author":"Amir M","year":"2000","journal-title":"Isr J Psychiatry Relat Sci"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008968401068"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.12.040"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-2755"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1098-3015(10)63957-5"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2014.06.005"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1470.2008.00782.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2012.04630.x"},{"key":"e_1_2_8_13_1","article-title":"Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: results from the ATMOS\u20101 and ATMOS\u20102 phase 3 randomized controlled trials","author":"Glaser DA","journal-title":"J Am Acad Dermatol"},{"key":"e_1_2_8_14_1","doi-asserted-by":"crossref","unstructured":"GlaserD HebertA FehnelS et\u00a0al.The axillary sweating daily diary: A validated patient\u2010reported outcome measure to assess axillary hyperhidrosis symptom severity. Poster presented at 13th Annual Maui Derm for Dermatologists 2017 Maui HI.","DOI":"10.25251\/skin.1.supp.93"},{"key":"e_1_2_8_15_1","article-title":"Development and validation of the Axillary Sweating Daily Diary: a patient\u2010reported outcome measure to assess sweating severity","author":"Nelson L","journal-title":"J Pat Rep Outcome"},{"key":"e_1_2_8_16_1","unstructured":"Guidance for Industry: Patient\u2010Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. In: U.S. Food & Drug Administration (FDA);2009."},{"issue":"8","key":"e_1_2_8_17_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_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.1994.tb01167.x"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0846.2007.00282.x"},{"key":"e_1_2_8_20_1","article-title":"Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: patient reported outcomes from the ATMOS\u20101 and ATMOS\u20102 phase 3 randomized controlled trials","author":"Pariser DM","journal-title":"Am J Clin Dermatol"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP201694"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00403-012-1266-9"},{"key":"e_1_2_8_23_1","unstructured":"QBREXZA\u2122 (glycopyrronium) cloth 2.4% for topical use. Prescribing Information.Dermira Inc. Menlo Park CA.2018."},{"key":"e_1_2_8_24_1","unstructured":"GlaserDA HebertAA NastA et\u00a0al.Open\u2010label study (ARIDO) evaluating long\u2010term safety of topical glycopyrronium tosylate (GT) in patients with primary axillary hyperhidrosis. Poster presentation presented at 35th Annual Fall Clinical Dermatology Conference 2017 Las Vegas NV."},{"key":"e_1_2_8_25_1","unstructured":"HebertAA GlaserDA GreenL et\u00a0al.Short\u2010 and Long\u2010Term Efficacy and Safety of Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Post Hoc Pediatric Subgroup Analyses from the Phase 3 Studies. Paper presented at: 27th International Congress of the European Academy of Dermatology and Venereology; September 12\u201016 2018 Paris France."},{"issue":"4","key":"e_1_2_8_26_1","first-page":"392","article-title":"Understanding patient experience with hyperhidrosis: a national survey of 1,985 patients","volume":"17","author":"Glaser DA","year":"2018","journal-title":"J Drugs Dermatol"},{"key":"e_1_2_8_27_1","unstructured":"BOTOX (onabotulinumtoxinA) for injection for intramuscular intradetrusor or intradermal use. Prescribing Information.Allergan Inc. Irvine CA.2011."},{"key":"e_1_2_8_28_1","unstructured":"miraDry System [510(k)].Miramar Labs Inc. Santa Clara CA 2016."},{"key":"e_1_2_8_29_1","first-page":"633","article-title":"Efficacy and compliance of oral glycopyrrolate in the treatment of primary hyperhidrosis in pediatric patients","volume":"302013","author":"Diaz L","year":"2013","journal-title":"Pediatr Dermatol"},{"issue":"8","key":"e_1_2_8_30_1","first-page":"S26","article-title":"Transdermal systems for overactive bladder: principles and practice","volume":"5","author":"Staskin DR","year":"2003","journal-title":"Rev Urol"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0773.1998.tb01456.x"},{"key":"e_1_2_8_32_1","volume-title":"Prescribing Information","author":"CUVPOSA\u00ae (glycopyrrolate) Oral Solution","year":"2015"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/pde.13404"}],"updated-by":[{"DOI":"10.1111\/pde.13877","type":"erratum","label":"Erratum","source":"publisher","updated":{"date-parts":[[2019,5,17]],"date-time":"2019-05-17T00:00:00Z","timestamp":1558051200000}}],"container-title":["Pediatric Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fpde.13723","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.13723","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/pde.13723","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.13723","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T08:13:26Z","timestamp":1693988006000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pde.13723"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,19]]},"references-count":32,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,1]]}},"alternative-id":["10.1111\/pde.13723"],"URL":"https:\/\/doi.org\/10.1111\/pde.13723","archive":["Portico"],"relation":{},"ISSN":["0736-8046","1525-1470"],"issn-type":[{"value":"0736-8046","type":"print"},{"value":"1525-1470","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,19]]},"assertion":[{"value":"2018-11-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}