A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Other: Vehicle; Drug: glycopyrrolate, 1.0%; Drug: glycopyrrolate, 2.0%; Drug: glycopyrrolate, 3.0%; Drug: glycopyrrolate, 4.0%

Detailed Description

This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
    • Little Rock, Arkansas, United States, 72202
      • Gary M. Petrus, MD, PA
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
  • Florida
    • Miami, Florida, United States, 33136
      • Florida Academic Dermatology Center
    • West Palm Beach, Florida, United States, 33401
      • Kenneth R. Beer, MD, PA
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center, LLC
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, PC
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.
    • Richmond, Virginia, United States, 23233
      • WestEnd Dermatology Associates
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, 18 years of age or older.
• Primary, axillary hyperhidrosis of at least 6 months duration.
• A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
• A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
• Male or non-pregnant, non-lactating females.

Exclusion Criteria:

• Prior surgical procedure for hyperhidrosis.
• Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
• Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
• Prior axillary treatment with axillary iontophoresis within 4 weeks.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Known history of a condition that may cause secondary hyperhidrosis.
• Known history of Sjögren's syndrome or Sicca syndrome.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Vehicle Topical Wipes	Other: Vehicle; Vehicle Topical Wipes; Other Names: Placebo
Experimental: glycopyrrolate, 1.0%; glycopyrrolate Topical Wipes, 1.0%	Drug: glycopyrrolate, 1.0%; glycopyrrolate Topical Wipes, 1.0%; Other Names: DRM04B
Experimental: glycopyrrolate, 2.0%; glycopyrrolate Topical Wipes, 2.0%	Drug: glycopyrrolate, 2.0%; glycopyrrolate Topical Wipes, 2.0%; Other Names: DRM04B
Experimental: glycopyrrolate, 3.0%; glycopyrrolate Topical Wipes, 3.0%	Drug: glycopyrrolate, 3.0%; glycopyrrolate Topical Wipes, 3.0%; Other Names: DRM04B
Experimental: glycopyrrolate, 4.0%; glycopyrrolate Topical Wipes, 4.0%	Drug: glycopyrrolate, 4.0%; glycopyrrolate Topical Wipes, 4.0%; Other Names: DRM04B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4	Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.	Baseline - Week 4
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4	HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (Best), 2, 3, 4 (Worst)	Baseline - Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4		Baseline - Week 4
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6		Baseline - Week 6
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6		Baseline - Week 6
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4	The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.	Baseline - Week 4

Collaborators and Investigators

• Sponsor: Journey Medical Corporation

Publications and helpful links

General Publications

• Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimate): December 20, 2013

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: DRM04-HH01