Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).

Subjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.

All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.

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