Back to resultsSafety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WL8713, 6 mg
WL8713, 12 mg
WL8713, 18 mg
WL8713, 24 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility 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
Sites / Locations
- Watson Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
WL8713, 6 mg
WL8713, 12 mg
WL8713, 18 mg
WL8713, 24 mg
Placebo
Arm Description
6 mg WL8713 administered daily
12 mg WL8713 administered daily
18 mg WL8713 administered daily
24 mg WL8713 administered daily
placebo administered daily
Outcomes
Primary Outcome Measures
Gravimetric measurement of sweat production
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
Secondary Outcome Measures
Hyperhidrosis Disease Severity Scale (HDSS) scores
Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
Dermatology Life Quality Index (DLQI) scores
Change from baseline in DLQI total score at Week 6 (LOCF)
Global Assessment of Disease State responses
Global Assessment of Disease State score at Week 6 (LOCF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02193139
Brief Title
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
Official Title
A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WL8713, 6 mg
Arm Type
Experimental
Arm Description
6 mg WL8713 administered daily
Arm Title
WL8713, 12 mg
Arm Type
Experimental
Arm Description
12 mg WL8713 administered daily
Arm Title
WL8713, 18 mg
Arm Type
Experimental
Arm Description
18 mg WL8713 administered daily
Arm Title
WL8713, 24 mg
Arm Type
Experimental
Arm Description
24 mg WL8713 administered daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo administered daily
Intervention Type
Drug
Intervention Name(s)
WL8713, 6 mg
Intervention Type
Drug
Intervention Name(s)
WL8713, 12 mg
Intervention Type
Drug
Intervention Name(s)
WL8713, 18 mg
Intervention Type
Drug
Intervention Name(s)
WL8713, 24 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Gravimetric measurement of sweat production
Description
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hyperhidrosis Disease Severity Scale (HDSS) scores
Description
Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
Time Frame
6 weeks
Title
Dermatology Life Quality Index (DLQI) scores
Description
Change from baseline in DLQI total score at Week 6 (LOCF)
Time Frame
6 weeks
Title
Global Assessment of Disease State responses
Description
Global Assessment of Disease State score at Week 6 (LOCF)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Watson Clinical Site
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
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