Open-Label Cohort Study to Evaluate Efficacy and Safety of Application of Glycopyrronium Cloth, 2.4% for Palmar Hyperhidrosis

May 2022 | Volume 21 | Issue 5 | Original Article | 488 | Copyright © May 2022


Published online April 29, 2022

doi:10.36849/JDD.6688

David M. Pariser MD, Erin Rivera MS, Danielle Benedict

Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, VA

Abstract
Background: Hyperhidrosis of the palms has a significant negative impact on quality of life. There is no FDA-approved treatment; however, clinicians often use glycopyrronium cloth off-label for this indication despite the lack of published guidance on optimal method of application for treatment of palms.
Objective: To compare the safety and efficacy of 4 different methods of application of glycopyrronium cloth to give clinicians guidance when treating palmar hyperhidrosis.
Study Design: This study, conducted completely virtually using live interactive telemedicine, compared application times of 15 minutes, 30 minutes, and overnight without occlusion and 30 minutes under occlusion. The primary endpoint was a decrease in the mean of the Hand Severity Score (HHS) after 4 weeks of once-daily application. Safety data, including local skin reactions and other adverse events, were tabulated by cohort.
Results: Of the application times and methods tested, 30 minutes without occlusion produced the greatest decrease in the HHS with an acceptable safety profile. The most common adverse event was unilateral mydriasis, which presumably occurred from inadvertent introduction of study drug into the eye despite multiple warnings to the subjects to avoid eye contact. A few subjects had adverse events presumably due to systemic absorption of the drug similar to those seen in the pivotal trials for treatment of axillary hyperhidrosis.
Conclusion: Glycopyrronium cloth can be used successfully to treat palmar hyperhidrosis. Occlusion for 30 minutes had the poorest response presumably due to the increased sweating causing dilution of the study drug.
ClinicalTrials.gov: NCT04906655

J Drugs Dermatol. 2022;21(5):488-494. doi:10.36849/JDD.6688

INTRODUCTION

Hyperhidrosis (HH) is a disorder of eccrine sweat production in an amount in excess of what is needed for thermoregulation. It is estimated that HH affects 4.8% of the US population or about 15.3 million people and produces a significant impact on quality of life.1-4

Glycopyrronium tosylate cloth (GC) (QBREXZA® Journey Medical Corporation, Scottsdale, Arizona) is a topical anticholinergic approved in the U.S. in 2018 for treatment of primary axillary hyperhidrosis in patients ≥9 years.5-7 In an algorithm for treatment of primary axillary hyperhidrosis developed by the International Hyperhidrosis Society, GC and topical antiperspirants are recommended as first-line treatment.8 Clinicians often use GC off-label to treat body areas other than the axilla, especially the palms, but there is no published guidance on efficacy, safety, or optimal method of palmar applications. Oral anticholinergics are commonly used off-label to treat hyperhidrosis of the palms and other body areas, but their utility is often limited by anticholinergic adverse effects, such as dry mouth and blurred vision, which can occur at doses required for efficacy.9

The purpose of this study was to compare four different methods of palmar application of GC using Patient-Reported Outcomes (PRO’s) to determine if a difference in efficacy and/or safety could be determined with different methods of application. There was no placebo-control group, and there were no statistical analyses performed, so determination of the true efficacy for treatment of palmar HH with GC was not the purpose of and cannot be determined by this study.

Study Design and Subject Selection
One hundred twenty subjects, age nine years or older, with self-reported excessive sweating of the palms, who met the