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

Phase 3

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: Glycopyrronium Topical Wipes

• Registration Number: NCT02553798
• Lead Sponsor: Journey Medical Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-18
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Disposition First Submitted: 2018-01-11
• Disposition First Submitted QC: 2018-01-11
• Disposition First Posted: 2018-01-16
• Results First Submitted: 2018-07-20
• Results First Submitted QC: 2018-08-28
• Results First Posted: 2018-09-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycopyrronium	Glycopyrronium Topical Wipes	Glycopyrronium Topical Wipes

Primary Outcome Measures

Name	Time	Method
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions	Day 1 - Week 44	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.

Trial Locations

Locations (48)

Skin Care Research, Inc.; 🇺🇸 Boca Raton, Florida, United States

Northwest Arkansas Clinical Trials Center, PLLC; 🇺🇸 Rogers, Arkansas, United States

Study Protocol, Inc; 🇺🇸 Boynton Beach, Florida, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Tory Sullivan, MD; 🇺🇸 North Miami Beach, Florida, United States

Prairie Health and Wellness; 🇺🇸 Wichita, Kansas, United States

Lawrence J. Green M.D., LLC; 🇺🇸 Rockville, Maryland, United States

Dermatology and Laser Center of Charleston, PA; 🇺🇸 Charleston, Pennsylvania, United States

DermResearch; 🇺🇸 Austin, Texas, United States

Modern Research Associates, PLLC; 🇺🇸 Dallas, Texas, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

The University of Texas Dermatology Clinical Research Center; 🇺🇸 Houston, Texas, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Texas Dermatology and Laser Specialists; 🇺🇸 San Antonio, Texas, United States

Dermatology Research Center, Inc.; 🇺🇸 Salt Lake City, Utah, United States

Clinical Research Associates, Inc; 🇺🇸 Nashville, Tennessee, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Coastal Medical Research Group LLC; 🇺🇸 Mobile, Alabama, United States

Colorado Medical Research Center, Inc; 🇺🇸 Denver, Colorado, United States

Research Institute of the Southeast; 🇺🇸 West Palm Beach, Florida, United States

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

The Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Zel Skin & Laser Specialist; 🇺🇸 Edina, Minnesota, United States

MediSearch Clinical Trials; 🇺🇸 Saint Joseph, Missouri, United States

St. Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Schweiger Dermatology Group; 🇺🇸 New York, New York, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Skin Search of Rochester, Inc; 🇺🇸 Rochester, New York, United States

J & S Studies, Inc.; 🇺🇸 College Station, Texas, United States

Austin Institute for Clinical Research; 🇺🇸 Pflugerville, Texas, United States

ACRC Trials; 🇺🇸 Plano, Texas, United States

Jordan Valley Dermatology Center, LLC; 🇺🇸 West Jordan, Utah, United States

Pro DERMA im Hautzentrum Dulmen; 🇩🇪 Dülmen, Germany

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Dermatology Associates; 🇺🇸 Seattle, Washington, United States

Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité; 🇩🇪 Berlin, Germany

Medical Practice and Derma-Study-Center Friedrichshafen GmbH; 🇩🇪 Friedrichshafen, Germany

Hautarztpraxis; 🇩🇪 Glückstadt, Germany

SRH Wald-Klinikum Gera GmbH; 🇩🇪 Gera, Germany

Gemeinschaftspraxis Weber & Cranic; 🇩🇪 Schweinfurt, Germany

Dermatolosche Gemeinschaftspraxis; 🇩🇪 Mahlow, Germany

Tagesklinik DermaKiel; 🇩🇪 Kiel, Germany

Rivergate Dermatology Research Center, PLLC; 🇺🇸 Goodlettsville, Tennessee, United States