Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129660
• Other study ID #: DRM04-HH02
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: January 2015

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 the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Description:

This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• 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.

• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.

• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.

• Male or non-pregnant, non-lactating females.

Exclusion Criteria:

• Current pregnancy or lactation.

• Prior surgical procedure for hyperhidrosis.

• Any prior axillary treatment with an anti-hyperhidrosis medical device

• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.

• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.

• Subjects with clinically significant abnormalities in laboratory values.

• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.

• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.

• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.

• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit

• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.

• Any previous IV or oral treatment with the study drug.

• Prior treatment with the topical study drug in a previous trial.

• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.

• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis

• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.

• Known history of Sjögren's syndrome or Sicca syndrome.

• History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

• Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

• Abnormal findings on screening ECG deemed clinically significant by the Investigator.

• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• Dose 1 of glycopyrrolate, 2.0% QD
Dose 1 of glycopyrrolate Topical Wipes
• Dose 2 of glycopyrrolate, 3.0% QD
Dose 2 of glycopyrrolate Topical Wipes
• Dose 1 of glycopyrronium, 2.5% QD
Dose 1 of glycopyrronium Topical Wipes
• Dose 2 of glycopyrronium, 3.75% QD
Dose 2 of glycopyrronium Topical Wipes

Other:
• Vehicle
Vehicle Topical Wipes

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montreal
United States	DermResearch, Inc	Austin	Texas
United States	Haber Dermatology and Cosmetic Surgery	Beachwood	Ohio
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Center For Dermatology Clinical Research	Fremont	California
United States	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Dermatology Associates	Seattle	Washington
United States	Women's Clinical Research Center	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	Olympian Clinical Research	Tampa	Florida
United States	Kenneth R. Beer MD	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Journey Medical Corporation

Countries where clinical trial is conducted

United States,  Canada, 

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/ET
Primary	Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4		Baseline - Week 4
Primary	Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6		Baseline - Week 6
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
Primary	Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6		Baseline - Week 6
Secondary	Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4		Baseline - Week 4
Secondary	Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6		Baseline - Week 6