Skip to main content
OpenTrials
Completed

NCT Number: NCT00931359

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Focal Hyperhidrosis, Axilla Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser and Skin Surgery Center of Northern California, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DTS-G2 System

Device

Treatment with microwave energy

DTS System (Sham treatment)

Device

Sham treatment - no energy is delivered

Primary outcomes

  1. 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:

    • - 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

Secondary outcomes

  1. 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:

    • - 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

  2. 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.

    • - 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Miramar Labs

Industry

Registry information

Official study title

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

Acronym: DRI-UP

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 2, 2009
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.