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

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ClinicalTrials.gov Identifier: NCT00931359
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : June 14, 2011
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Miramar Labs

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Focal Hyperhidrosis, Axilla
Interventions Device: DTS-G2 System
Device: DTS System (Sham treatment)
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description Subjects received a sham treatment in two treatment sessions. Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Period Title: Overall Study
Started 39 81
Completed 33 68
Not Completed 6 13
Arm/Group Title Sham Treatment Treatment With DTS-G2 System Total
Hide Arm/Group Description Subjects received a sham treatment in two treatment sessions. Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J. Total of all reporting groups
Overall Number of Baseline Participants 39 81 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 81 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
80
  98.8%
119
  99.2%
>=65 years
0
   0.0%
1
   1.2%
1
   0.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 81 participants 120 participants
34.1  (11.2) 32.2  (10.7) 32.8  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 81 participants 120 participants
Female
26
  66.7%
44
  54.3%
70
  58.3%
Male
13
  33.3%
37
  45.7%
50
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 81 participants 120 participants
39 81 120
1.Primary Outcome
Title Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Hide 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:

  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
Time Frame 30 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description:
Subjects received a sham treatment in two treatment sessions.
Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Overall Number of Participants Analyzed 39 81
Measure Type: Number
Unit of Measure: Percentage of Participants
54 89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Treatment, Treatment With DTS-G2 System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments Factors of treatment group and analysis center were considered
2.Secondary Outcome
Title Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
Hide 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:

  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
Time Frame 6 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description:
Subjects received a sham treatment in two treatment sessions.
Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Overall Number of Participants Analyzed 39 81
Measure Type: Number
Unit of Measure: Percentage of Participants
44 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Treatment, Treatment With DTS-G2 System
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
Hide Description

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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description:
Subjects received a sham treatment in two treatment sessions.
Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Overall Number of Participants Analyzed 0 81
Measure Type: Number
Unit of Measure: Percentage of Participants
69
4.Secondary Outcome
Title Percentage of Subjects With Reported Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description:
Subjects received a sham treatment in two treatment sessions.
Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Overall Number of Participants Analyzed 39 81
Measure Type: Number
Unit of Measure: Percentage of Participants
13 28
Time Frame Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment
Adverse Event Reporting Description Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.
 
Arm/Group Title Sham Treatment Treatment With DTS-G2 System
Hide Arm/Group Description Subjects received a sham treatment in two treatment sessions. Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
All-Cause Mortality
Sham Treatment Treatment With DTS-G2 System
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sham Treatment Treatment With DTS-G2 System
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/81 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham Treatment Treatment With DTS-G2 System
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      13/81 (16.05%)    
Skin and subcutaneous tissue disorders     
Altered sensation *  1/39 (2.56%)  1 8/81 (9.88%)  9
Pain/soreness *  2/39 (5.13%)  2 5/81 (6.17%)  6
*
Indicates events were collected by non-systematic assessment
Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathy O'Shaughnessy, PhD
Organization: Miramar Labs
Phone: 408-940-8700
EMail: kathyo@miramarlabs.com
Layout table for additonal information
Responsible Party: Kathy O'Shaughnessy, VP Clinical/Regulatory, Miramar Labs, Inc
ClinicalTrials.gov Identifier: NCT00931359     History of Changes
Other Study ID Numbers: CP-0003
First Submitted: June 28, 2009
First Posted: July 2, 2009
Results First Submitted: April 15, 2011
Results First Posted: June 14, 2011
Last Update Posted: June 15, 2011