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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

Conditions
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Primary Focal Hyperhidrosis, Axilla

Intervention / Treatment
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* Device: DTS-G2 System
* Device: DTS System (Sham treatment)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with DTS-G2 System<br>Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used. | Device: DTS-G2 System<br>* Treatment with microwave energy<br>|
| Sham Comparator: Sham treatment<br>All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used. | Device: DTS System (Sham treatment)<br>* Sham treatment - no energy is delivered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. | 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: - My underarm sweating is never noticeable and never interferes with my daily activities - My underarm sweating is tolerable but sometimes interferes with my daily activities - My underarm sweating is barely tolerable and frequently interferes with my daily activities - My underarm sweating is intolerable and always interferes with my daily activities | 30 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. | 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: - My underarm sweating is never noticeable and never interferes with my daily activities - My underarm sweating is tolerable but sometimes interferes with my daily activities - My underarm sweating is barely tolerable and frequently interferes with my daily activities - My underarm sweating is intolerable and always interferes with my daily activities | 6 months post-treatment | 
| Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit | The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating. - My underarm sweating is never noticeable and never interferes with my daily activities - My underarm sweating is tolerable but sometimes interferes with my daily activities - My underarm sweating is barely tolerable and frequently interferes with my daily activities - 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. | 12 months | 
| Percentage of Subjects With Reported Adverse Events | 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. | 6 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillary, hyperhidrosis, primary focal