Trial reportPediatric dermatology2020
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.
Trial report in Pediatric dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Efficacy and safety of topical glycopyrronium bromide in treating axillary hyperhidrosis: systematic review and meta-analysis.Scientific reports · 2024Pooled it
- Topical glycopyrronium tosylate in Japanese patients with primary axillary hyperhidrosis: A randomized, double-blind, vehicle-controlled study.The Journal of dermatology · 2022Trial
- Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis.Clinical pharmacokinetics · 2021Trial
- 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 · 2020Trial
- Primary Hyperhidrosis: A Review of Epidemiology, Pathophysiology and Management.Acta dermato-venereologica · 2026Review
- Primary hyperhidrosis: an updated review.Drugs in context · 2025Review
- Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents.Pharmacotherapy · 2023Review
- Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics.Dermatology and therapy · 2022Review
- Treatment of Hyperhidrosis: An Update.American journal of clinical dermatology · 2022Review
- Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis: A Profile of Its Use.Clinical drug investigation · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 1 country.
Funding
Abstract
BACKGROUND/
objectivesGlycopyrronium 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).
methodsIn 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.
resultsOf 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.
conclusionsLong-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.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.