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The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the treatment of unwanted tattoos.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosure Laser System | Experimental | Picosure Laser System for the Treatment of Unwanted Tattoos |
|
| Revlite Laser System | Experimental | Revlite Laser System for the Treatment of Unwanted Tattoos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picosure Laser System | Device | Picosure Laser System for the Treatment of Unwanted Tattoos |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tattoo Clearance | Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is >75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance. | 2 months post each patient's last treatment, approximately 15 months |
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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 |
|---|---|---|---|---|---|---|
| Cynosure Inc. | Westford | Massachusetts | 01886 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Picosure Laser System | Picosure Laser System for the Treatment of Unwanted Tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos |
| FG001 | Revlite Laser System | Revlite Laser System for the Treatment of Unwanted Tattoos Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Picosure Laser System | Picosure Laser System for the Treatment of Unwanted Tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos |
| BG001 | Revlite Laser System |
| 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 | Tattoo Clearance | Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is >75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance. | 11 Picosure subjects were lost to follow up, 2 subjects withdrew, and 7 subjects were not required to attend the follow up because the study was ended. | Posted | Mean | Standard Deviation | score on a scale | 2 months post each patient's last treatment, approximately 15 months | tattoos | tattoos |
|
Adverse Events will be collected for each patient's participation in the study, about 15 months. Adverse events that are not resolved by this time will be followed up with until the condition resolves, stabilizes, or is otherwise explained, or the subject is lost to follow-up.
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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 | Picosure Laser System | Picosure Laser System for the Treatment of Unwanted Tattoos Picosure Laser System: Picosure Laser System for the Treatment of Unwanted Tattoos |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2020 | Dec 28, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 1, 2016 | Jan 22, 2021 | Prot_001.pdf |
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| Revlite Laser System | Device | Revlite Laser System for the Treatment of Unwanted Tattoos |
|
Revlite Laser System for the Treatment of Unwanted Tattoos
Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | 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 |
Revlite Laser System for the Treatment of Unwanted Tattoos Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 45 |
| 58 |
| EG001 | Revlite Laser System | Revlite Laser System for the Treatment of Unwanted Tattoos Revlite Laser System: Revlite Laser System for the Treatment of Unwanted Tattoos | 0 | 5 | 0 | 5 | 5 | 5 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pinpoint Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scabs | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | 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.