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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: Placebo; Drug: WL8713, 6 mg; Drug: WL8713, 12 mg; Drug: WL8713, 18 mg; Drug: WL8713, 24 mg

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States
      • Watson Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WL8713, 6 mg; 6 mg WL8713 administered daily	Drug: WL8713, 6 mg
Experimental: WL8713, 12 mg; 12 mg WL8713 administered daily	Drug: WL8713, 12 mg
Experimental: WL8713, 18 mg; 18 mg WL8713 administered daily	Drug: WL8713, 18 mg
Experimental: WL8713, 24 mg; 24 mg WL8713 administered daily	Drug: WL8713, 24 mg
Placebo Comparator: Placebo; placebo administered daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gravimetric measurement of sweat production	Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 weeks
Dermatology Life Quality Index (DLQI) scores	Change from baseline in DLQI total score at Week 6 (LOCF)	6 weeks
Global Assessment of Disease State responses	Global Assessment of Disease State score at Week 6 (LOCF)	6 weeks

Collaborators and Investigators

• Sponsor: Watson Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 29, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: OH1304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No