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The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of unwanted tattoos
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Picosure Laser System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picosure Laser System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tattoo Clearance Percentage Using a Photographic Scale | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo. | 1-3 month follow up post each subject's last treatment, an average of 17.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Satisfaction | Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0). | Baseline and 2 months post last treatment follow up (+/- 1 month) |
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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 New York | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Picosure Laser System | Subjects will be treated with 1064nm, 532nm, or 755nm in combination or individually, depending on the color of the tattoo and the skin type of the subject. Since the purpose of the study is to test the overall clearance of the tattoo, breaking the results down by wavelengths is extraneous information. The primary purpose of the study is not to compare the wavelengths against each other, but rather, to examine the overall clearance created by the Picosure Laser System. Furthermore, each wavelength is designed to target a specific color, so a multi-colored tattoo will have a variety of wavelengths used (in combination and individually), all for the primary objective of indicating overall tattoo clearance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Picosure Laser System | Picosure 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 Percentage Using a Photographic Scale | Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo. | 12 subjects were lost to follow up, and 5 subjects withdrew consent. | Posted | Mean | Standard Deviation | percentage of clearance | 1-3 month follow up post each subject's last treatment, an average of 17.5 months | tattoos | tattoos |
|
Adverse Events occurring will be captured and followed throughout the patients' participation in the study, approximately 23 months.
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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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- 532 nm Wavelength | Picosure Laser System, using a frequency of 532 nm |
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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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| Subject Satisfaction | Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0). | Baseline and 2 months post last treatment follow up (+/- 1 month) |
| Participants |
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| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| tattoos |
|
|
| Secondary | Investigator Satisfaction | Questionnaires were used to assess Investigator satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0). | 12 subjects were lost to follow up, and 5 subjects withdrew consent. | Posted | Count of Units | tattoos | Baseline and 2 months post last treatment follow up (+/- 1 month) | tattoos | tattoos |
|
|
|
| Secondary | Subject Satisfaction | Questionnaires were used to assess Subject satisfaction at the post last treatment follow up visit with their cosmetic results when compared to baseline photos using a four point scale ranging from "extremely satisfied" (3) to "extremely dissatisfied" (0). | 12 subjects were lost to follow up, and 5 subjects withdrew consent. | Posted | Count of Units | tattoos | Baseline and 2 months post last treatment follow up (+/- 1 month) | tattoos | tattoos |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 27 |
| 27 |
| EG001 | Picosure Laser System- 755 nm Wavelength | Picosure Laser System, using a frequency of 755 nm | 0 | 27 | 0 | 27 | 27 | 27 |
| EG002 | Picosure Laser System- 1064 nm Wavelength | Picosure Laser System, using a frequency of 1064 nm | 0 | 41 | 0 | 41 | 41 | 41 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pinpoint Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Scabbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | 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.
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| Number of Tattoo Results Investigator Was Extremely Satisfied With |
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| Number of Tattoo Subjects Were Extremely Satisfied With |
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