Status:
COMPLETED
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Lead Sponsor:
Miramar Labs
Conditions:
Primary Focal Hyperhidrosis, Axilla
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 undera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00931359
Start Date
June 1 2009
End Date
December 1 2010
Last Update
June 15 2011
Active Locations (7)
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1
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
Bay Area Center for Plastic Surgery
Sunnyvale, California, United States, 94085
4
The Coleman Clinic
Metairie, Louisiana, United States, 70006