A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperhidrosis

In brief

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Key facts

Study ID

NCT02016885

Run by

Journey Medical Corporation

People needed

198

Starts

2013-11-01

Expected to finish

2014-09-01

Last updated by the study team

2021-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years of age or older.
• Primary, axillary hyperhidrosis of at least 6 months duration.
• A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
• A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
• Male or non-pregnant, non-lactating females.

You may not qualify if…

• Prior surgical procedure for hyperhidrosis.
• Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
• Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
• Prior axillary treatment with axillary iontophoresis within 4 weeks.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Known history of a condition that may cause secondary hyperhidrosis.
• Known history of Sjögren's syndrome or Sicca syndrome.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Gary M. Petrus, MD, PA — Little Rock, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Center For Dermatology Clinical Research — Fremont, California, United States
• Florida Academic Dermatology Center — Miami, Florida, United States
• Kenneth R. Beer, MD, PA — West Palm Beach, Florida, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Cypress Medical Research Center, LLC — Wichita, Kansas, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Saint Louis University Dermatology — St Louis, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• The Dermatology Group, PC — Verona, New Jersey, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• J&S Studies, Inc. — College Station, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Westend Dermatology Associates — Richmond, Virginia, United States
• Dermatology Associates — Seattle, Washington, United States
• Women's Clinical Research Center — Seattle, Washington, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.