Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Completed · Not applicable · Has a placebo group
Conditions studied: Primary Focal Hyperhidrosis, Axilla
In brief
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.
Key facts
- Study ID
- NCT00931359
- Run by
- Miramar Labs
- People needed
- 120
- Starts
- 2009-06-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Laser and Skin Surgery Center of Northern California — Sacramento, California, United States
- Therapeutics Clinical Research — San Diego, California, United States
- Bay Area Center for Plastic Surgery — Sunnyvale, California, United States
- The Coleman Clinic — Metairie, Louisiana, United States
- Skin Care Physicians — Chestnut Hill, Massachusetts, United States
- St Louis University — St Louis, Missouri, United States
- The Dermatology Group — Verona, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.