Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553798
• Other study ID #: DRM04-HH06
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: December 2016

Study information

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

Clinical Trial Summary

This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Description:

Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance

• Male or females

Exclusion Criteria:

• Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated

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

• Any other condition which, in the judgement 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
Glycopyrronium Topical Wipes

Locations

Country	Name	City	State
Germany	Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité	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	Gemeinschaftspraxis Weber & Cranic	Schweinfurt
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch	Austin	Texas
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	Study Protocol, Inc	Boynton Beach	Florida
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Dermatology and Laser Center of Charleston, PA	Charleston	Pennsylvania
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	J & S Studies, Inc.	College Station	Texas
United States	Modern Research Associates, PLLC	Dallas	Texas
United States	Colorado Medical Research Center, Inc	Denver	Colorado
United States	Zel Skin & Laser Specialist	Edina	Minnesota
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Rivergate Dermatology Research Center, PLLC	Goodlettsville	Tennessee
United States	The University of Texas Dermatology Clinical Research Center	Houston	Texas
United States	Dermatology Research Associates	Los Angeles	California
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Coastal Medical Research Group LLC	Mobile	Alabama
United States	Clinical Research Associates, Inc	Nashville	Tennessee
United States	Schweiger Dermatology Group	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Tory Sullivan, MD	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, PC	Plainfield	Indiana
United States	ACRC Trials	Plano	Texas
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Skin Search of Rochester, Inc	Rochester	New York
United States	Lawrence J. Green M.D., LLC	Rockville	Maryland
United States	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	St. Louis University Dermatology	Saint Louis	Missouri
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Dermatology Associates	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	Jordan Valley Dermatology Center, LLC	West Jordan	Utah
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
Other	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.	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Other	Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)	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.	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Other	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET	The Dermatology Life Quality Index 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 (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Primary	Long-term Safety Assessed Through Adverse Events and Local Skin Reactions	The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.	Day 1 - Week 44