Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00931359
Eligibility Criteria:
Inclusion Criteria:
* baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla
* poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale
* primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria
* female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period
* female subjects over 40 must have had a mammogram in the last 2 years
* subjects must be willing to comply with study visits and requirements
Exclusion Criteria:
* subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)
* subject has active infection
* subject is pregnant or lactating
* subject has had prior surgery for axillary hyperhidrosis
* subject has had axillary injections of botulinum toxin A in the last year
* subject has used prescription antiperspirants in the last 14 days or plans to use them during the study period
* subject has used oral anticholinergics in the last 4 weeks
* subject is a prisoner or under incarceration
* subject is participating in a another clinical trial (or has in the last 30 days)
* subject has history of cancer (some exceptions)
* subject has a pacemaker or other electronic implant
* subject requires supplemental oxygen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00931359
Study Brief:
Protocol Section:
NCT00931359