Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

Completed · Phase 2

Conditions studied: Hyperhidrosis

In brief

The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Key facts

Study ID

NCT02129660

Run by

Journey Medical Corporation

People needed

105

Starts

2014-04-01

Expected to finish

2015-01-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older, up to 99. 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.
• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
• Male or non-pregnant, non-lactating females.

You may not qualify if…

• Current pregnancy or lactation.
• Prior surgical procedure for hyperhidrosis.
• Any prior axillary treatment with an anti-hyperhidrosis medical device
• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
• Subjects with clinically significant abnormalities in laboratory values.
• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
• Any previous IV or oral treatment with the study drug.
• Prior treatment with the topical study drug in a previous trial.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
• Known 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.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.
• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Center For Dermatology Clinical Research — Fremont, California, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Kenneth R. Beer MD — West Palm Beach, Florida, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Saint Louis University Dermatology — St Louis, Missouri, United States
• Haber Dermatology and Cosmetic Surgery — Beachwood, Ohio, United States
• Rivergate Dermatology Clinical Research Center, PLLC — Goodlettsville, Tennessee, United States
• DermResearch, Inc — Austin, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• Virginia Clinical Research, Inc. — Norfolk, 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
• Innovaderm Research Inc. — Montreal, Canada

Full record on ClinicalTrials.gov

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