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

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016885
• Other study ID #: DRM04-HH01
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2021
• Source: Journey Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
• glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
• glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
• glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%

Other:
• Vehicle
Vehicle Topical Wipes

Locations

Country	Name	City	State
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	J&S Studies, Inc.	College Station	Texas
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Center For Dermatology Clinical Research	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Gary M. Petrus, MD, PA	Little Rock	Arkansas
United States	Florida Academic Dermatology Center	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Oregon Medical Research Center	Portland	Oregon
United States	Westend Dermatology Associates	Richmond	Virginia
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Dermatology Associates	Seattle	Washington
United States	Women's Clinical Research Center	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	The Dermatology Group, PC	Verona	New Jersey
United States	Kenneth R. Beer, MD, PA	West Palm Beach	Florida
United States	Cypress Medical Research Center, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Journey Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4		Baseline - Week 4
Secondary	Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6		Baseline - Week 6
Secondary	Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6		Baseline - Week 6
Secondary	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