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Collaboration with company that made the laser did not proceed.
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| Name | Class |
|---|---|
| Sciton | INDUSTRY |
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Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life.
The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated side | Experimental | Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands. |
|
| Untreated side | No Intervention | Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser treatment | Device | Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Gravimetric Measurements of Changes in Sweat Production | Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated. | Assessed at baseline, week 1, week 2, week 4, month 3, and month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital - Wellman Center for Photomedicine | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Side | Two regions are designated, one on each palm and randomized to treatment or control. The treatment side receives laser treatment of the sweat glands. Laser treatment: Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation. |
| FG001 | Untreated Side | Two regions are designated, one on each palm and randomized to treatment and control sides. The control side is untreated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a split-person study where all participants were allocated to both treatment and control groups. Two regions were designated, one on each palm, and randomized to treatment or control. The treatment side receives laser treatment of the sweat glands. The control side receives no intervention. On the treatment side, iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation. |
| 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 | Gravimetric Measurements of Changes in Sweat Production | Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated. | Subject 1 missed week 1 and week 3 visits. | Posted | Mean | Standard Deviation | grams | Assessed at baseline, week 1, week 2, week 4, month 3, and month 6 |
|
6 months
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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 | Treated Side | Two regions are designated one on each palm. Randomized to treatment and control sides. Treatment side receives laser treatment of the sweat glands. Laser treatment: Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yakir Levin | Massachusetts General hospital | 6177262914 | ylevin2@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2020 | May 15, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2020 | Apr 14, 2026 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).
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| Palms |
|
| Participants |
| Participants |
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| Age, Continuous | 2 subjects were analyzed. Each subject had a treatment side and a control side. Thus there were a total of two subjects with a total of 4 sides (2 treatment and 2 control). | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Gravimetric measurements of changes in sweat production | Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated. | Mean | Standard Deviation | grams | Palms |
|
| OG001 | Untreated Side | Two test sites are chosen on the palms (one on each palm) and randomized to treatment or control sides. The control side is untreated. |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Untreated Side | Two regions are designated, one on each palm. Randomized to treatment and control sides. Control side is untreated. | 0 | 2 | 0 | 2 | 0 | 2 |
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