Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (DRI-UP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95816
- Laser and Skin Surgery Center of Northern California
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San Diego, California, United States, 92123
- Therapeutics Clinical Research
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Sunnyvale, California, United States, 94085
- Bay Area Center for Plastic Surgery
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Louisiana
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Metairie, Louisiana, United States, 70006
- The Coleman Clinic
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Skin Care Physicians
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Missouri
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St. Louis, Missouri, United States, 63104
- St Louis University
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New Jersey
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Verona, New Jersey, United States, 07044
- The Dermatology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment with 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.
|
Treatment with microwave energy
|
|
Sham Comparator: Sham treatment
All elements of the treatment are given except that no energy is delivered.
Multiple treatment sessions may be used.
|
Sham treatment - no energy is delivered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Time Frame: 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:
|
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.
Time Frame: 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:
|
6 months post-treatment
|
|
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
Time Frame: 12 months
|
The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.
|
12 months
|
|
Percentage of Subjects With Reported Adverse Events
Time Frame: 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.
|
6 months post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dee Anna Glaser, MD, St. Louis University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-0003
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