Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (DRI-UP)

This study has been completed.
Sponsor:
Information provided by:
Miramar Labs
ClinicalTrials.gov Identifier:
NCT00931359
First received: June 28, 2009
Last updated: June 13, 2011
Last verified: June 2011

June 28, 2009
June 13, 2011
June 2009
December 2009   (final data collection date for primary outcome measure)
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]

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
Not Provided
Complete list of historical versions of study NCT00931359 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]

    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
  • Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.
  • Percentage of Subjects With Reported Adverse Events [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: Yes ]
    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.
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Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Primary Focal Hyperhidrosis, Axilla
  • Device: DTS-G2 System
    Treatment with microwave energy
    Other Name: DTS-G2 System
  • Device: DTS System (Sham treatment)
    Sham treatment - no energy is delivered
  • 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.
    Intervention: Device: DTS-G2 System
  • Sham Comparator: Sham treatment
    All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.
    Intervention: Device: DTS System (Sham treatment)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931359
CP-0003
Yes
Kathy O'Shaughnessy, VP Clinical/Regulatory, Miramar Labs, Inc
Miramar Labs
Not Provided
Principal Investigator: Dee Anna Glaser, MD St. Louis University
Miramar Labs
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP