The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of unwanted tattoos.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Picosecond Laser System for the Treatment of Unwanted Tattoos
Washington Institute of Dermatologic Laser Surgery
Washington D.C., District of Columbia, United States
New York Laser and Skin Care
New York, New York, United States
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States
Global percentage of tattoo clearance
Global percentage of tattoo clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.
Time frame: 3 months post the final treatment
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.
Time frame: 3 months
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