Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (DRI-UP)

Miramar Labs

Status

Completed

Conditions

Primary Focal Hyperhidrosis, Axilla

Treatments

Device: DTS-G2 System

Device: DTS System (Sham treatment)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931359

CP-0003

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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