Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

Not Applicable

Completed

Conditions: Primary Focal Hyperhidrosis, Axilla

Interventions: Device: DTS-G2 System
Device: DTS System (Sham treatment)

Registration Number: NCT00931359

Lead Sponsor: Miramar Labs

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with DTS-G2 System	DTS-G2 System	Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.
Sham treatment	DTS System (Sham treatment)	All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.	30 days post-treatment	The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors: 1. - My underarm sweating is never noticeable and never interferes with my daily activities 2. - My underarm sweating is tolerable but sometimes interferes with my daily activities 3. - My underarm sweating is barely tolerable and frequently interferes with my daily activities 4. - My underarm sweating is intolerable and always interferes with my daily activities

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.	6 months post-treatment	The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors: 1. - My underarm sweating is never noticeable and never interferes with my daily activities 2. - My underarm sweating is tolerable but sometimes interferes with my daily activities 3. - My underarm sweating is barely tolerable and frequently interferes with my daily activities 4. - My underarm sweating is intolerable and always interferes with my daily activities
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit	12 months	The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating. 1. - My underarm sweating is never noticeable and never interferes with my daily activities 2. - My underarm sweating is tolerable but sometimes interferes with my daily activities 3. - My underarm sweating is barely tolerable and frequently interferes with my daily activities 4. - My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit.
Percentage of Subjects With Reported Adverse Events	6 months post-treatment	Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.

Trial Locations

Locations (7): Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Bay Area Center for Plastic Surgery
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Sunnyvale, California, United States
The Coleman Clinic
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Metairie, Louisiana, United States
St Louis University
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St. Louis, Missouri, United States
Skin Care Physicians
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Chestnut Hill, Massachusetts, United States
The Dermatology Group
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Verona, New Jersey, United States
Laser and Skin Surgery Center of Northern California
🇺🇸
Sacramento, California, United States