Trial Outcomes & Findings for Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis (NCT NCT00931359)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

30 days post-treatment

Results posted on

2011-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Treatment Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Overall Study STARTED	39	81
Overall Study COMPLETED	33	68
Overall Study NOT COMPLETED	6	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Treatment n=39 Participants Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 Participants Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=93 Participants	80 Participants n=4 Participants	119 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Age Continuous	34.1 years STANDARD_DEVIATION 11.2 • n=93 Participants	32.2 years STANDARD_DEVIATION 10.7 • n=4 Participants	32.8 years STANDARD_DEVIATION 10.8 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	44 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	37 Participants n=4 Participants	50 Participants n=27 Participants
Region of Enrollment United States	39 participants n=93 Participants	81 participants n=4 Participants	120 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days post-treatment

Population: Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.

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

Outcome measures

Outcome measures
Measure	Sham Treatment n=39 Participants Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 Participants Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.	54 Percentage of Participants	89 Percentage of Participants

SECONDARY outcome

Timeframe: 6 months post-treatment

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

Outcome measures

Outcome measures
Measure	Sham Treatment n=39 Participants Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 Participants Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.	44 Percentage of Participants	67 Percentage of Participants

SECONDARY outcome

Timeframe: 12 months

Population: Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.

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.

Outcome measures

Outcome measures
Measure	Sham Treatment Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 Participants Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit	—	69 Percentage of Participants

SECONDARY outcome

Timeframe: 6 months post-treatment

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.

Outcome measures

Outcome measures
Measure	Sham Treatment n=39 Participants Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 Participants Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Percentage of Subjects With Reported Adverse Events	13 Percentage of Participants	28 Percentage of Participants

Adverse Events

Sham Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment With DTS-G2 System

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sham Treatment n=39 participants at risk Subjects received a sham treatment in two treatment sessions.	Treatment With DTS-G2 System n=81 participants at risk Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
Skin and subcutaneous tissue disorders Altered sensation	2.6% 1/39 • Number of events 1 • Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.	9.9% 8/81 • Number of events 9 • Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.
Skin and subcutaneous tissue disorders Pain/soreness	5.1% 2/39 • Number of events 2 • Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.	6.2% 5/81 • Number of events 6 • Sham group subjects followed for 6 months post-treatment. Treatment group subjects followed for 12 months post-treatment Only adverse events judged by investigator as being possibly, to definitely related to the device or procedure are listed.

Additional Information

Kathy O'Shaughnessy, PhD

Miramar Labs

Phone: 408-940-8700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60