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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.; Journey Medical Corporation
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.