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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Primary Focal Hyperhidrosis, Axilla
Interventions:	Device: DTS-G2 System Device: DTS System (Sham treatment)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Sham Treatment	Treatment With DTS-G2 System
STARTED	39	81
COMPLETED	33	68
NOT COMPLETED	6	13

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Sham Treatment	Treatment With DTS-G2 System	Total
Number of Participants [units: participants]	39	81	120
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	39	80	119
>=65 years	0	1	1
Age [units: years] Mean ± Standard Deviation	34.1 ± 11.2	32.2 ± 10.7	32.8 ± 10.8
Gender [units: participants]
Female	26	44	70
Male	13	37	50
Region of Enrollment [units: participants]
United States	39	81	120

Outcome Measures

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1. Primary:

Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. [ Time Frame: 30 days post-treatment ]

Measure Type	Primary
Measure Title	Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.

Reporting Groups

	Description
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.

Measured Values

	Sham Treatment	Treatment With DTS-G2 System
Number of Participants Analyzed [units: participants]	39	81
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days. [units: Percentage of Participants]	54	89

Statistical Analysis 1 for Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Factors of treatment group and analysis center were considered
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Sham Treatment	Treatment With DTS-G2 System
Number of Participants Analyzed [units: participants]	39	81
Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit. [units: Percentage of Participants]	44	67

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

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	0.019

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Secondary:

Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit [ Time Frame: 12 months ]

Measure Type	Secondary
Measure Title	Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.

Reporting Groups

	Description
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.

Measured Values

	Sham Treatment	Treatment With DTS-G2 System
Number of Participants Analyzed [units: participants]	0	81
Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit [units: Percentage of Participants]		69

No statistical analysis provided for Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit

4. Secondary:

Percentage of Subjects With Reported Adverse Events [ Time Frame: 6 months post-treatment ]

Measure Type	Secondary
Measure Title	Percentage of Subjects With Reported Adverse Events
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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.

Measured Values

	Sham Treatment	Treatment With DTS-G2 System
Number of Participants Analyzed [units: participants]	39	81
Percentage of Subjects With Reported Adverse Events [units: Percentage of Participants]	13	28

No statistical analysis provided for Percentage of Subjects With Reported Adverse Events

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.

Results Point of Contact:

Name/Title: Kathy O'Shaughnessy, PhD
Organization: Miramar Labs
phone: 408-940-8700
e-mail: kathyo@miramarlabs.com

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

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