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Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser
This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single or multi-color ink. Subjects will receive laser treatments, and will be followed at 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Enlighten Device | Experimental | Tattoo removal treatments with the investigational Cutera enlighten laser |
|
| Cynosure PicoSure 755 nm laser | Active Comparator | Tattoo removal treatments with the Cynosure PicoSure 755 nm laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutera enlighten laser | Device | high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing | 6 weeks post-final treatment, an average of 8 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Lezaic, DO | Laser Skin Solutions Jacksonville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Skin Solutions Jacksonville | Jacksonville Beach | Florida | 32250 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Treatment - Cutera Enlighten Laser | Full tattoo will be treated with the Cutera enlighten laser |
| FG001 | Split Tattoo Treatment - Cutera Enligthen Laser | Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser. The investigational treatment will be assigned to either part A (right/top side) or part B (left/lower side) of the tattoo (based on patient's left and right). |
| FG002 | Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser | Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Treatment | Full tattoo will be treated with the Cutera enlighten laser |
| BG001 | Split Tattoo Treatment | Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser. |
| 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 | Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement) | Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-final treatment, an average of 8 months from baseline |
|
6 weeks post final treatment, up to 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 | Single Arm Treatment - Cutera Enlighten Laser | Full tattoo will be treated with the Cutera enlighten laser |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-656-9612 | mdoucette@cutera.com |
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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 | Sep 29, 2016 | Aug 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| CynoSure PicoSure 755nm laser | Device | high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Split Tattoo Treatment- PicoSure | Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Split Tattoo Treatment - Cutera Enlighten Laser | Tattoo will be split and treated with the Cutera enlighten laser and the Cynosure PicoSure 755 nm laser. The investigational treatment will be assigned to either part A (right/top side) or part B (left/lower side) of the tattoo (based on patient's left and right). | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | Split Tattoo Treatment - Cynosure PicoSure 755 nm Laser | Tattoo will be split and treated with the Cynosure PicoSure 755 nm laser. | 0 | 5 | 0 | 5 | 5 | 5 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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