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

Completed · Phase 3

Conditions studied: Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT02553798

Run by

Journey Medical Corporation

People needed

564

Starts

2015-08-01

Expected to finish

2016-12-01

Last updated by the study team

2021-08-25

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Coastal Medical Research Group LLC — Mobile, Alabama, United States
• Northwest Arkansas Clinical Trials Center, PLLC — Rogers, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Colorado Medical Research Center, Inc — Denver, Colorado, United States
• Skin Care Research, Inc. — Boca Raton, Florida, United States
• Study Protocol, Inc — Boynton Beach, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Tory Sullivan, MD — North Miami Beach, Florida, United States
• Research Institute of the Southeast — West Palm Beach, Florida, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Prairie Health and Wellness — Wichita, Kansas, United States
• Lawrence J. Green M.D., LLC — Rockville, Maryland, United States
• Zel Skin & Laser Specialist — Edina, Minnesota, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• St. Louis University Dermatology — St Louis, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Schweiger Dermatology Group — New York, New York, United States
• Skin Search of Rochester, Inc — Rochester, New York, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Dermatology and Laser Center of Charleston, PA — Charleston, Pennsylvania, United States

Full record on ClinicalTrials.gov

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