Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.

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

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Cholinergic Antagonists

Criteria

Inclusion Criteria:

• Healthy volunteers with primary axillary hyperhidrosis

• Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)

• Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla

• Meets at least two of the following criteria (self-reported):

• sweating is bilateral and symmetrical

• excessive sweating impairs daily activities

• subject experiences at least one sweating episode per week

• excessive sweating onset was earlier than age 25 years

• has a positive family history for excessive sweating

• cessation of sweating during sleep