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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sham treatment | Sham Comparator | All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTS-G2 System | Device | Treatment with microwave energy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dee Anna Glaser, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Treatment | Subjects received a sham treatment in two treatment sessions. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Treatment | Subjects received a sham treatment in two treatment sessions. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Intent to Treat Population was used. Last Observation Carry Forward was used for missing data. | Posted | Number | Percentage of Participants | 30 days post-treatment |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Treatment | Subjects received a sham treatment in two treatment sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Sham subjects exited the study at 6 months, so group comparisons are not possible for later timepoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy O'Shaughnessy, PhD | Miramar Labs | 408-940-8700 | kathyo@miramarlabs.com |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| DTS System (Sham treatment) |
| Device |
Sham treatment - no energy is delivered |
|
| 6 months post-treatment |
| 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.
| 12 months |
| 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. | 6 months post-treatment |
| Therapeutics Clinical Research |
| San Diego |
| California |
| 92123 |
| United States |
| Bay Area Center for Plastic Surgery | Sunnyvale | California | 94085 | United States |
| The Coleman Clinic | Metairie | Louisiana | 70006 | United States |
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| St Louis University | St Louis | Missouri | 63104 | United States |
| The Dermatology Group | Verona | New Jersey | 07044 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
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| Secondary | 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:
| Posted | Number | Percentage of Participants | 6 months post-treatment |
|
|
|
|
| Secondary | 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.
| Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint. | Posted | Number | Percentage of Participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Number | Percentage of Participants | 6 months post-treatment |
|
|
|
| 0 |
| 39 |
| 3 |
| 39 |
| EG001 | 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. | 0 | 81 | 13 | 81 |
| Pain/soreness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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