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The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revlite Laser System- Single Wavelength | Experimental | Revlite Laser System- 1064nm wavelength will be used on half of the face. |
|
| Revlite Laser System- Dual Wavelength | Experimental | Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlite Laser System | Device | Revlite Laser System for the Treatment of Facial Solar Lentigines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved. | 1 month post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Satisfaction Questionnaire | The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1). | 1 month post last treatment |
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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 |
|---|---|---|---|---|---|---|
| Sadick Research Group | New York | New York | 10075 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Revlite Laser System | Revlite Laser System Revlite Laser System: Revlite Laser System with ½ of the face treated with the 1064nm wavelength and the other half of the face treated with combination of both the 1064nm and 532nm wavelengths. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Revlite Laser System | Revlite Laser System Revlite Laser System: Revlite Laser System for the Treatment of Facial Solar Lentigines |
| 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 | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved. | Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment. | Posted | Count of Participants | Participants | 1 month post last treatment |
|
Adverse events occurring will be captured and followed throughout each subject's participation in the study, approximately 8 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 | Revlite Laser System Single | Revlite Laser System Revlite Laser System 1064nm wavelength |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | 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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Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
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| 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 |
|
| OG001 |
| Revlite Laser System- Combo |
Revlite Laser System using 1064 nm and 532 nm wavelengths |
|
|
| Secondary | Physician Satisfaction Questionnaire | The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1). | Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment. | Posted | Median | Standard Deviation | score on a scale | 1 month post last treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Revlite Laser System Combo | Revlite Laser System Revlite Laser System: Combination of both the 1064nm and 532nm wavelengths | 0 | 10 | 0 | 10 | 9 | 10 |
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Acne | 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.