The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Picosecond Laser System for the Treatment of Pigmented Lesions
Laser and Cosmetic Dermatology
San Francisco, California, United States
Hong Kong Dermatology and Laser Centre
Hong Kong, China
Global percentage of pigment clearance
Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.
Time frame: 3 months post the final treatment
Number of Participants with Adverse Events
Adverse events will be evaluated immediately after and before each subsequent laser treatment and will be based on the incidence and severity of side effects caused by the laser treatments.
Time frame: 3 months
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