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

Purpose

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.

Condition	Intervention
Primary Focal Hyperhidrosis, Axilla	Device: DTS-G2 System Device: DTS System (Sham treatment)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis

Further study details as provided by Miramar Labs:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	120
Study Start Date:	June 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: DTS-G2 System Treatment with microwave energy Other Name: 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.	Device: DTS System (Sham treatment) Sham treatment - no energy is delivered

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931359

Locations

United States, California
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
Therapeutics Clinical Research
San Diego, California, United States, 92123
Bay Area Center for Plastic Surgery
Sunnyvale, California, United States, 94085
United States, Louisiana
The Coleman Clinic
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, Missouri
St Louis University
St. Louis, Missouri, United States, 63104
United States, New Jersey
The Dermatology Group
Verona, New Jersey, United States, 07044

Sponsors and Collaborators

Miramar Labs

Investigators

Principal Investigator:

Dee Anna Glaser, MD

St. Louis University

More Information

No publications provided

Responsible Party:	Kathy O'Shaughnessy, VP Clinical/Regulatory, Miramar Labs, Inc
ClinicalTrials.gov Identifier:	NCT00931359 History of Changes
Other Study ID Numbers:	CP-0003
Study First Received:	June 28, 2009
Results First Received:	April 15, 2011
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Miramar Labs:

axillary
hyperhidrosis
primary focal

Additional relevant MeSH terms:

Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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