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

Phase 2

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: WL8713, 6 mg; Drug: WL8713, 12 mg; Drug: WL8713, 18 mg; Drug: WL8713, 24 mg; Drug: Placebo

• Registration Number: NCT02193139
• Lead Sponsor: Watson Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-29
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Status Verified: 2014-11
• Disposition First Submitted: 2015-07-15
• Disposition First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Disposition First Posted: 2015-08-06
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WL8713, 6 mg	WL8713, 6 mg	6 mg WL8713 administered daily
WL8713, 12 mg	WL8713, 12 mg	12 mg WL8713 administered daily
WL8713, 18 mg	WL8713, 18 mg	18 mg WL8713 administered daily
WL8713, 24 mg	WL8713, 24 mg	24 mg WL8713 administered daily
Placebo	Placebo	placebo administered daily

Primary Outcome Measures

Name	Time	Method
Gravimetric measurement of sweat production	6 weeks	Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Disease State responses	6 weeks	Global Assessment of Disease State score at Week 6 (LOCF)
Hyperhidrosis Disease Severity Scale (HDSS) scores	6 weeks	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	6 weeks	Change from baseline in DLQI total score at Week 6 (LOCF)

Trial Locations

Locations (1)

Watson Clinical Site; 🇺🇸 San Diego, California, United States