Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of unwanted tattoos

Official Title
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Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos

Conditions
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Unwanted Tattoos

Intervention / Treatment
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* Device: Picosure Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old. Is willing to consent to participate in the study. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment Exclusion Criteria: The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. The subject is hypersensitive to light exposure OR takes photo sensitized medication. The subject has active or localized systemic infections. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. The subject has used Accutane within 6 months prior to enrollment. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). The subject has a history of keloids. The subject has evidence of compromised wound healing. The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosure Laser System<br> | Device: Picosure Laser System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |