Completed

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

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What is being tested

DTS-G2 System

+ DTS System (Sham treatment)

Device
Who is being recruted

Hyperhidrosis+1

+ Skin Diseases

+ Sweat Gland Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorMiramar Labs
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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 TitleA Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Principal SponsorMiramar Labs
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperhidrosisSkin DiseasesSweat Gland DiseasesSkin and Connective Tissue Diseases

Criteria

6 inclusion criteria required to participate
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

Show More Criteria

12 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.

Group II

Sham
All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Laser and Skin Surgery Center of Northern California

Sacramento, United StatesOpen Laser and Skin Surgery Center of Northern California in Google Maps
Suspended

Therapeutics Clinical Research

San Diego, United States
Suspended

Bay Area Center for Plastic Surgery

Sunnyvale, United States
Suspended

The Coleman Clinic

Metairie, United States
Completed7 Study Centers