An Open Label Study for Palmar Hyperhydrosis

Skin Diseases Clinical Trial

Official title: An Open-label Study to Evaluate the Efficacy and Safety of Different Methods of Application of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

Status Completed

Clinical Trial Summary

The purpose of this open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis

Clinical Trial Description

This study will assess glycopyrronium cloth, 2.4% in patients with primary palmar hyperhidrosis and compare the efficacy and safety of various application methods in order to determine an optimal method for use in palmar hyperhidrosis. The study will assess four application methods (treatment groups). Data from these cohorts will be reviewed on a continuous basis, and the protocol may be amended to add one or more treatment groups if required to determine the optional conditions of drug application.

This study is open label and unblinded. The treatment groups will be enrolled in cohorts, with each cohort being filled before moving on to the next. Cohort A will be enrolled first, followed by B, C, and D. Each cohort will have 30 subjects. If there are multiple AEs of special interest, the medical monitor may stop enrollment of one or more cohorts or may prematurely terminate a cohort(s).

All visits for this study will be conducted virtually, using HIPAA compliant video conferencing technology. Investigational product (IP) will be shipped overnight to subjects that are deemed eligible for participation.

All subjects will sign an informed e-consent and undergo screening for study eligibility. Key criteria for entry are: primary palmar hyperhidrosis for at least 6 months, an average hand sweat severity score of ≥4 (NRS 0-10 pts) during the screening period. Exclusion criteria includes pregnancy or lactation, secondary hyperhidrosis, prior sympathectomy, open wounds or infection on the hands, and concomitant use of iontophoresis, botulinum toxin, experimental therapy, or unstable doses of anticholinergic medications. Subjects will only be allowed to enroll into one cohort.

Approximately 120 eligible subjects, ≥9 years of age will be enrolled to one of four treatment groups at the Baseline visit.

Cohort Table 1: Treatment Groups A 30 minutes residence time in cotton gloves n=30 B 30 minutes residence time under occlusion n=30 C Overnight in cotton gloves n=30 D Overnight under occlusion n=30

Subjects will be instructed on the application method and will apply study drug at home once each evening before going to bed for 28 days (+/- 2 days). Subjects will complete virtual visits to check for adverse events (AEs) and study drug compliance at Week 1, Week 2, and Week 4. Subjects will exit the study at the Week 4 visit. ;

Related Conditions & MeSH terms

• Hyperhidrosis
• Palmar Hyperhidrosis
• Skin Diseases
• Sweat Gland Diseases

• NCT number: NCT04906655
• Study type: Interventional
• Source: Pariser, Robert J., M.D.
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2020
• Completion date: May 20, 2021