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.

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