Primary Focal Hyperhidrosis, Axilla Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment