Study of Glycopyrronium in Axillary Hyperhydrosis

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

NCT02530281

Run by

Journey Medical Corporation

People needed

344

Starts

2015-07-01

Expected to finish

2016-03-01

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

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Therapeutics Clinical Research — San Diego, California, 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, M.D., P.A. — North Miami Beach, Florida, United States
• Research Institute of the Southeast — West Palm Beach, Florida, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Prairie Health and Wellness — Wichita, Kansas, United States
• St. Louis University Dermatology — St Louis, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Dermatology and Laser Center — Charleston, South Carolina, United States
• Rivergate Dermatology Clinical Research Center, PLLC — Goodlettsville, Tennessee, United States
• DermResearch — Austin, Texas, United States
• J&S Studies — College Station, Texas, United States
• Austin Institute for Clinical Research — Pflugerville, Texas, United States
• ACRC Trials / Innovative Dermatology — Plano, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Charlottesville Dermatology Research Center — Charlottesville, Virginia, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite — 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

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.