Picosure Alexandrite 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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Picosure Alexandrite 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 male or female between 18 and 85 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. The tattoo must include red pigment. Exclusion Criteria: Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. Is hypersensitive to light exposure OR takes photo sensitized medication. Has active or localized systemic infections. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}). Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 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. Has used Accutane within 6 months prior to enrollment. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate). Has a history of keloids. Has evidence of compromised wound healing. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder. Is allergic to topical lidocaine or topical steroids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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>Picosure Laser System for the treatment of unwanted tattoos | Device: Picosure Laser System<br>* Picosure Laser System for the Treatment of Unwanted Tattoos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |