Status:
COMPLETED
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Hyperhidrosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 subj...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT02193139
Start Date
December 1 2013
End Date
June 1 2014
Last Update
August 6 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Watson Clinical Site
San Diego, California, United States