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The Purpose of the study is to evaluate the 1440nm Laser Assisted Selective Photothermolysis vs. Botulinum Toxin or miraDry® Microwave Thermolysis For Treatment of Axillary Hyperhidrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox® | Experimental | Botox® |
|
| miraDry® | Experimental | miraDry® |
|
| Nd: YAG laser | Experimental | Nd: YAG laser 1440nm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miraDry | Device | miraDry |
| |
| Nd:YAG Laser |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 1 month follow up |
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 3 month follow up |
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 6 month follow up |
| Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | 9 month follow up |
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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 |
|---|---|---|---|---|---|---|
| Sasaki Advanced Aesthetic Medical Center | Pasadena | California | 91105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nd: YAG Laser and miraDry | Nd: YAG laser 1440nm and miraDry For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with miraDry. The subject is treated with miraDry at day 0, and again at day 90. Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector. |
| FG001 | Nd: YAG Laser 1440nm and Botox | Nd: YAG laser 1440nm and Botox For each patient, one axilla was treated with the 1440 nm Diode laser and the opposite axilla was treated with Botox. Nd:YAG Laser: Nd:YAG 1440 nm Diode Laser with a Rep Rate of 25 Hz. Total energy around 1500 J per 5cm x 5cm sector. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nd: YAG Laser- miraDry | Nd: YAG laser 1440nm miraDry: miraDry |
| BG001 | Nd: YAG Laser- Botox | Nd:YAG Laser: Nd:YAG 1440 nm Laser Botox®: Botox® |
| 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 | Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | One subject in the Botox treatment was a no-show to their scheduled follow up. | Posted | Mean | Standard Deviation | mg | 1 month follow up |
|
Adverse Events occurring were collected throughout the study, around 18 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 | Botox® | Botox® and Nd:YAG Laser: 1440 nm Laser | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness | Skin and subcutaneous tissue 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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| Device |
Nd:YAG 1440 nm Laser |
|
| Botox® | Device | Botox® |
|
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| OG002 | Nd: YAG Laser | Nd: YAG laser 1440nm |
|
|
| Primary | Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | Posted | Mean | Standard Deviation | mg | 3 month follow up |
|
|
|
| Primary | Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | Posted | Mean | Standard Deviation | mg | 6 month follow up |
|
|
|
| Primary | Change in Sweating Assessed Using Gravimetry | A gravimetry test was performed to determine the quantity of sweat produced, comparing the post-treatment to the baseline numbers. A pre-weighted filter paper was placed on the armpit, and then weighed afterwards to determine the quantity of sweat produced. | The gravimetric test was not required for the 9 month follow up. | Posted | Mean | Standard Deviation | mg | 9 month follow up |
|
|
|
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | miraDry® | miraDry® and Nd:YAG 1440 nm Laser | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | Nd: YAG Laser | Nd: YAG laser: 1440nm | 0 | 17 | 0 | 17 | 17 | 17 |
| Pain | Nervous system disorders | Systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nodule | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hardness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.