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The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite Laser Single Pass (Right Side). | Experimental | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit. |
|
| 755nm Alexandrite Laser Double Pass (Left Side) | Experimental | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755 nm alexandrite laser | Device | 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 1 (6 Weeks Post Baseline) |
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 2 (12 Weeks Post Baseline) |
| Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Post Treatment 3 (18 Weeks Post Baseline) |
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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 |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States |
All subjects are enrolled in both study arms because all subjects will be receiving treatment on the left side of the tattoo and treatment on the right side of the tattoo in each visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos 755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 subject withdrew, per sponsor request, due to multiple laser devices already used on treatment area. They withdrew before baseline information was taken of them.
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| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos 755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. |
| 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 clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Posted | Mean | Standard Deviation | score on a scale | Post Treatment 1 (6 Weeks Post Baseline) | tattoos | tattoos |
|
Adverse data were collected from the first treatment until 3 months post-treatment.
The adverse events were reported in 1 group instead of 2 (right vs. left) because that distinction in adverse events collection was not examined or required for this study's aims.
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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 | 755nm Alexandrite Laser | 755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos 755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypopigmentation | 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 |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 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 |
|
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
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|
|
| Primary | Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Posted | Mean | Standard Deviation | score on a scale | Post Treatment 2 (12 Weeks Post Baseline) | tattoos | tattoos |
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| Primary | Tattoo Clearance | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo. | Posted | Mean | Standard Deviation | score on a scale | Post Treatment 3 (18 Weeks Post Baseline) | tattoos | tattoos |
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| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperpigmentation | 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.