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

NCT00931359 | Completed Results DMC

• 1 other identifier: CP-0003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Primary Focal Hyperhidrosis, Axilla

Keywords

axillary; hyperhidrosis; primary focal

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.

  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

  30 days post-treatment

Secondary Outcomes (3)

• Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.

  6 months post-treatment

• Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit

  12 months

• Percentage of Subjects With Reported Adverse Events

  6 months post-treatment

Study Arms (2)

Treatment with DTS-G2 System

EXPERIMENTAL

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

Sham treatment

SHAM COMPARATOR

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

Device: DTS System (Sham treatment)

Interventions

DTS-G2 System DEVICE

Treatment with microwave energy

Treatment with DTS-G2 System

DTS System (Sham treatment) DEVICE

Sham treatment - no energy is delivered

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miramar Labs: lead

Study Sites (7)

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Bay Area Center for Plastic Surgery

Sunnyvale, California, 94085, United States

Location

The Coleman Clinic

Metairie, Louisiana, 70006, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

St Louis University

St Louis, Missouri, 63104, United States

Location

The Dermatology Group

Verona, New Jersey, 07044, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.

Results Point of Contact

• Title: Kathy O'Shaughnessy, PhD
• Organization: Miramar Labs

kathyo@miramarlabs.com

408-940-8700

Study Officials

• Dee Anna Glaser, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 15, 2011
• Results First Posted: June 14, 2011

Record last verified: 2011-06

Locations

US (7)