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

Primary Purpose

Primary Focal Hyperhidrosis, Axilla

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DTS-G2 System
DTS System (Sham treatment)
Sponsored by
Miramar Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Focal Hyperhidrosis, Axilla focused on measuring axillary, hyperhidrosis, primary focal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laser and Skin Surgery Center of Northern California
  • Therapeutics Clinical Research
  • Bay Area Center for Plastic Surgery
  • The Coleman Clinic
  • Skin Care Physicians
  • St Louis University
  • The Dermatology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment with DTS-G2 System

Sham treatment

Arm Description

Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.

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

Outcomes

Primary Outcome Measures

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: - 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 Outcome Measures

Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
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
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
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.
Percentage of Subjects With Reported Adverse Events
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.

Full Information

First Posted
June 28, 2009
Last Updated
June 13, 2011
Sponsor
Miramar Labs
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1. Study Identification

Unique Protocol Identification Number
NCT00931359
Brief Title
Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Acronym
DRI-UP
Official Title
A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Miramar Labs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Focal Hyperhidrosis, Axilla
Keywords
axillary, hyperhidrosis, primary focal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with DTS-G2 System
Arm Type
Experimental
Arm Description
Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.
Intervention Type
Device
Intervention Name(s)
DTS-G2 System
Intervention Description
Treatment with microwave energy
Intervention Type
Device
Intervention Name(s)
DTS System (Sham treatment)
Intervention Description
Sham treatment - no energy is delivered
Primary Outcome Measure Information:
Title
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Description
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
Time Frame
30 days post-treatment
Secondary Outcome Measure Information:
Title
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
Description
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
Time Frame
6 months post-treatment
Title
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
Description
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.
Time Frame
12 months
Title
Percentage of Subjects With Reported Adverse Events
Description
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.
Time Frame
6 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dee Anna Glaser, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser and Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Bay Area Center for Plastic Surgery
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
The Coleman Clinic
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Skin Care Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
St Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
The Dermatology Group
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States

12. IPD Sharing Statement

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

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