Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT02530294

Run by

Journey Medical Corporation

People needed

353

Starts

2015-08-01

Expected to finish

2016-04-01

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…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwest Arkansas Clinical Trials Center, PLLC — Rogers, Arkansas, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Colorado Medical Research Center, Inc. — Denver, Colorado, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Lawrence J Green, MD LLC — Rockville, Maryland, United States
• Zel Skin & Laser Specialist — Edina, Minnesota, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Clinical Studies Group, LLC — Henderson, Nevada, 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
• Clinical Research Associates, Inc. — Nashville, Tennessee, United States
• Modern Research Associates — Dallas, Texas, United States
• The University of Texas Dermatology Clinical Research Center — Houston, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• Jordan Valley Dermatology Center — West Jordan, Utah, United States
• Dermatology Associates — Seattle, Washington, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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