Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
1 other identifier
interventional
195
1 country
1
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 subjects. The anticholinergic agent being studied is designated WL8713.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 17, 2014
CompletedAugust 6, 2015
November 1, 2014
6 months
June 29, 2014
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Gravimetric measurement of sweat production
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
6 weeks
Secondary Outcomes (3)
Hyperhidrosis Disease Severity Scale (HDSS) scores
6 weeks
Dermatology Life Quality Index (DLQI) scores
6 weeks
Global Assessment of Disease State responses
6 weeks
Study Arms (5)
WL8713, 6 mg
EXPERIMENTAL6 mg WL8713 administered daily
WL8713, 12 mg
EXPERIMENTAL12 mg WL8713 administered daily
WL8713, 18 mg
EXPERIMENTAL18 mg WL8713 administered daily
WL8713, 24 mg
EXPERIMENTAL24 mg WL8713 administered daily
Placebo
PLACEBO COMPARATORplacebo administered daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Watson Clinical Site
San Diego, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2014
First Posted
July 17, 2014
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 6, 2015
Record last verified: 2014-11