NCT00931359

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Miramar Labs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Focal Hyperhidrosis, Axilla

Interventions

Type	Name	Description
DEVICE	DTS-G2 System	Treatment with microwave energy
DEVICE	DTS System (Sham treatment)	Sham treatment - no energy is delivered

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2009-07-02
• Last updated: 2011-06-15
• Results posted: 2011-06-14

Locations

7 sites across 1 country: United States