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OpenTrials
Completed

NCT Number: NCT02193139

Safety and Efficacy of an Anticholinergic Agent for 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.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Watson Clinical Site

San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WL8713, 6 mg

Drug

WL8713, 12 mg

Drug

WL8713, 18 mg

Drug

WL8713, 24 mg

Drug

Placebo

Drug

Primary outcomes

  1. Gravimetric measurement of sweat production

    Time frame: 6 weeks

    Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)

Secondary outcomes

  1. Hyperhidrosis Disease Severity Scale (HDSS) scores

    Time frame: 6 weeks

    Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)

  2. Dermatology Life Quality Index (DLQI) scores

    Time frame: 6 weeks

    Change from baseline in DLQI total score at Week 6 (LOCF)

  3. Global Assessment of Disease State responses

    Time frame: 6 weeks

    Global Assessment of Disease State score at Week 6 (LOCF)

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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