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

Miramar Labs120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Primary Focal Hyperhidrosis, Axilla

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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: 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

Time frame: 30 days post-treatment

Secondary Outcomes

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

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. 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.

Time frame: 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.

Time frame: 6 months post-treatment