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The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nd:YAG Laser | Experimental | Nd:YAG 1440nm Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nd:YAG Laser | Device | Nd:YAG 1440nm Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | 3 Month Follow Up |
| Percentage of Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | 6 Month Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juva Skin and Laser Center | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nd:YAG Laser | Nd:YAG 1440nm Laser Nd:YAG Multiwavelength Diode Laser Using 1440nm Wavelength. A Rep Rate of 25 Hz was used. Each subject received 1 treatment using this laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nd:YAG Laser | Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser |
| Units | Counts |
|---|---|
| Participants |
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| 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 Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | The subject was lost to follow up (not due to adverse events). | Posted | Mean | Standard Deviation | % of photographs identified correctly | 3 Month Follow Up |
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Adverse events were collected for the study duration, around 12 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 | Nd:YAG Laser | Nd:YAG 1440nm Laser Nd:YAG Laser: Nd:YAG 1440nm Laser | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.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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| up to 3 months post last treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Score | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes from this source: Gupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010 | Count of Participants | Participants |
|
|
| Primary | Percentage of Photographs Identified Accurately | 3 trained blinded evaluators were asked to pick the post treatment photo from pre and post treatment photograph sets. | Anything beyond the 3 month follow up was not required, and the subject chose not to come in. | Posted | Mean | Standard Deviation | % of photographs identified correctly | 6 Month Follow Up |
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|
|
| Secondary | Number of Participants With Changed and Unchanged Glands on Biopsy Sampling | Hematoxylin and eosin (H&E) staining was performed on all pre and post treatment biopsy samples and evaluated by a pathologist to determine if there was any change in the subjects' glands at baseline vs. post last treatment. Changes in glands are characterized by reduction in quantity and size, in addition to changes in shape. | The biopsy portion of the study was optional, so there were only 5 subjects. | Posted | Count of Participants | Participants | up to 3 months post last treatment |
|
|
|
| 19 |
| 0 |
| 19 |
| 19 |
| 19 |
| Pain | Nervous system disorders | Systematic Assessment |
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| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nodule | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hardness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.