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.

Abstract

BACKGROUND/OBJECTIVES:

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).

METHODS:

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.

RESULTS:

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, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials.

CONCLUSIONS:

Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.

• Authors: Adelaide A Hebert, Dee Anna Glaser, Lawrence Green, Cheryl Hull, Jennifer Cather, Janice Drew, Ramanan Gopalan, David M Pariser
• Journal: Pediatric dermatology (Pediatr Dermatol) Vol. 37 Issue 3 Pg. 490-497 (May 2020) ISSN: 1525-1470 [Electronic] United States
• PMID: 32147881 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2020 The Authors. Pediatric Dermatology published by Wiley Periodicals, Inc.

Chemical References

• Cholinergic Antagonists
• glycopyrronium tosylate
• Glycopyrrolate

Topics

• Axilla
• Child
• Cholinergic Antagonists
• Double-Blind Method
• Glycopyrrolate (adverse effects)
• Humans
• Hyperhidrosis (drug therapy)
• Treatment Outcome