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Clinical trialNCT00931359CompletedInterventional

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

SponsorMiramar LabsEnrollment120Primary Focal Hyperhidrosis, Axilla
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2009
Primary completion
31 Dec 2009
Completion
31 Dec 2010
Last update posted
15 Jun 2011
Registered enrollment
120
Registry id
NCT00931359

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.