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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 | Picosure 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 |
|---|---|---|
| Number of Patients With Tattoo Clearance | Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo. | 2 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Satisfaction Questionnaire | This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied. | 2 months 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 |
|---|---|---|---|---|---|---|
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | 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 |
| 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 |
| 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 | Number of Patients With Tattoo Clearance | Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo. | Posted | Count of Participants | Participants | 2 months post last treatment |
|
|
Adverse events were collected for the study duration, around 19 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 | 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 |
|---|---|---|---|---|---|
| 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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One of the subjects did not report his/her race/ethnicity. | 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 |
|
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| Secondary | Physician Satisfaction Questionnaire | This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied. | Posted | Count of Participants | Participants | 2 months post last treatment |
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| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pinpoint Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Allergic Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | 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.