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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT01722461
Eligibility Criteria:
Inclusion Criteria:
* Male and female, age 18 years or older.
* Subject is in good health.
* Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
* At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
* A HDSS score of 3 or 4
* Willingness to comply with study visits and requirements
* Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1
* Female subjects over 40 years of age must have had a mammogram in the last 2 years
Exclusion Criteria:
* Has a dermal disorder including infection at anticipated treatment sites in either axilla.
* Has had axillary injections of botulinum toxin in the last year.
* Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
* Has a known allergy to starch powder, iodine, or lidocaine.
* Has secondary hyperhidrosis
* Has had previous surgical treatment of hyperhidrosis
* Has had prior miraDry treatment for axillary hyperhidrosis.
* Has used prescription antiperspirants in the last 14 days or plans to use them during the study period.
* Inability to withhold use of non-study-supplied antiperspirants and deodorants
* Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments.
* History of previous Ultherapy™ treatment to the axilla.
* Has a history of a bleeding disorder
* Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis in the past 4 weeks.
* Is a prisoner or under incarceration.
* Is participating in another clinical trial involving the use of investigational devices or drugs (or has in the last 30 days.)
* Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy.
* Has a pacemaker or other electronic implant.
* Requires supplemental oxygen.
* Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in the past 6 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01722461
Study Brief:
Protocol Section:
NCT01722461