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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02193139

Enrollment

195

Registered

2014-07-17

Start date

2013-12-31

Completion date

2014-06-30

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperhidrosis

Brief 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.

Interventions

DRUGWL8713, 6 mg

DRUGWL8713, 12 mg

DRUGWL8713, 18 mg

DRUGWL8713, 24 mg

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Hyperhidrosis Disease Severity Scale (HDSS) scores	6 weeks	Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
Dermatology Life Quality Index (DLQI) scores	6 weeks	Change from baseline in DLQI total score at Week 6 (LOCF)
Global Assessment of Disease State responses	6 weeks	Global Assessment of Disease State score at Week 6 (LOCF)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026