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

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperhidrosis

Treatments: Drug: WL8713, 12 mg; Drug: WL8713, 6 mg; Drug: WL8713, 24 mg; Drug: WL8713, 18 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193139

OH1304

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 5 patient groups, including a placebo group

WL8713, 6 mg

Experimental group

Description:

6 mg WL8713 administered daily

Treatment:

Drug: WL8713, 6 mg

WL8713, 12 mg

Experimental group

Description:

12 mg WL8713 administered daily

Treatment:

Drug: WL8713, 12 mg

WL8713, 18 mg

Experimental group

Description:

18 mg WL8713 administered daily

Treatment:

Drug: WL8713, 18 mg

WL8713, 24 mg

Experimental group

Description:

24 mg WL8713 administered daily

Treatment:

Drug: WL8713, 24 mg

Placebo

Placebo Comparator group

Description:

placebo administered daily

Treatment:

Drug: Placebo