Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study

Pediatric Dermatology
Adelaide HebertDavid M Pariser

Abstract

Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294). In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children's Dermatology Life Quality Index. Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, re...Continue Reading

References

Jun 1, 1995·The British Journal of Dermatology·M S Lewis-Jones, A Y Finlay
May 1, 1994·Clinical and Experimental Dermatology·A Y Finlay, G K Khan
Jul 29, 2004·Journal of the American Academy of Dermatology·David R StruttonPaul E Stang
Apr 17, 2008·Skin Research and Technology : Official Journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI)·Marianne BrandtKlaus-Peter Wilhelm
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Oct 17, 2016·Archives of Dermatological Research·James DoolittleJane Thurston
Oct 28, 2016·Dermatology and Therapy·Daniel A Grabell, Adelaide A Hebert

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Citations

Jan 13, 2021·Clinical Pharmacokinetics·David M PariserDiane R Mould
Mar 5, 2021·Pediatric Dermatology·Courtney RemingtonAdelaide A Hebert
Aug 21, 2021·Journal of Cosmetic Dermatology·Gulhima AroraMohamad Goldust

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Clinical Trials Mentioned

NCT02530281
NCT02530294
NCT02553789

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