Study of Glycopyrronium in Axillary Hyperhydrosis

Hyperhidrosis Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530281
• Other study ID #: DRM04-HH04
• Secondary ID: 2015-002052-27
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: March 2016

Study information

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

Clinical Trial Summary

The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Description:

This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Male or female = 9 years of age.

• Primary, axillary hyperhidrosis of at least 6 months duration

• Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline

• Axillary Sweating Daily Diary (ASDD) = 4 at Baseline

• Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically

Exclusion Criteria:

• Prior surgical procedure for hyperhidrosis.

• Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).

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

• Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

• Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.

• Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.

• Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.

• Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

• Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.

• 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.

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

• Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• glycopyrronium Topical Wipes
Topical wipes containing glycopyrronium

Other:
• Vehicle
Vehicle (placebo) topical wipes

Locations

Country	Name	City	State
Germany	Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite	Berlin
Germany	Pro DERMA im Hautzentrum Dulmen	Dülmen
Germany	Medical Practice and Derma Study Center Friedrichshafen GmbH	Friedrichshafen
Germany	SRH Wald-Klinikum Gera GmbH	Gera
Germany	Hautarztpraxis	Glückstadt
Germany	Tagesklinik DermaKiel	Kiel
Germany	Dermatolosche Gemeinschaftspraxis	Mahlow
Germany	Hautarztpraxis	Pinneberg
Germany	Gemeinschaftspraxis Weber & Cranic	Schweinfurt
Germany	Hautarztpraxis	Stuttgart
United States	DermResearch	Austin	Texas
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	Study Protocol, Inc.	Boynton Beach	Florida
United States	Dermatology and Laser Center	Charleston	South Carolina
United States	Charlottesville Dermatology Research Center	Charlottesville	Virginia
United States	J&S Studies	College Station	Texas
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	ACRC Trials / Innovative Dermatology	Plano	Texas
United States	St. Louis University Dermatology	Saint Louis	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Research Institute of the Southeast	West Palm Beach	Florida
United States	Prairie Health and Wellness	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Journey Medical Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Have a =4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4	The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: During the past 24 hours, did you have any underarm sweating? (Yes or No); During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating); During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount); During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)	From Baseline to Week 4
Primary	Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at 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.	From Baseline to Week 4
Primary	Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4		From Baseline to Week 4
Primary	Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data		Baseline - Week 4
Secondary	Percentage of Subjects Who Have a =2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4	Hyperhidrosis Disease Severity Scale (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)	From Baseline to Week 4
Secondary	Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4		From Baseline to Week 4