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

Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193139
• Other study ID #: OH1304
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2014
• Last updated: July 15, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• WL8713, 6 mg

• WL8713, 12 mg

• WL8713, 18 mg

• WL8713, 24 mg

• Placebo

Locations

Country	Name	City	State
United States	Watson Clinical Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gravimetric measurement of sweat production	Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)	6 weeks	No
Secondary	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	No
Secondary	Dermatology Life Quality Index (DLQI) scores	Change from baseline in DLQI total score at Week 6 (LOCF)	6 weeks	No
Secondary	Global Assessment of Disease State responses	Global Assessment of Disease State score at Week 6 (LOCF)	6 weeks	No