Laser Treatment of Tattoos With Pico Laser

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.

Detailed Description
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The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps. A multicenter study.

Official Title
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LASER TREATMENT OF TATTOOS WITH A DUAL WAVELENGTH PICOSECOND LASER

Conditions
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Unwanted Tattoos

Intervention / Treatment
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* Device: Picosecond Laser system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has Fitzpatrick skin type I-IV Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them 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 Exclusion Criteria: Is hypersensitive to light exposure Has an active sun tan Has Fitzpatrick skin type V or VI Has active localized or systemic infection Is taking medication(s) for which sunlight is a contraindication Has a history of squamous cell carcinoma or melanoma Has a history of keloid scarring Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications 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 allergic to lidocaine, tetracaine or Xylocaine with epinephrine

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosecond Laser System<br> | Device: Picosecond Laser system<br>* Picosecond 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 |
| --- | --- | --- |
| Global percentage of tattoo clearance | Global percentage of tattoo clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs. | 3 months post the final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tattoo clearance | The average number of treatments will be determined in order to obtain 50% and 75% tattoo clearance. Rate of clearance will be assessed globally independent of tattoo color and based on individual colors. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tattoos, Picosecond Laser, Syneron