This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment. Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, United States
RECRUITINGBlinded evaluation of pigmentation clearance
Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos.
Time frame: 8 weeks post final treatment
Global percentage of pigmentation clearance
Global percentage of pigmentation clearance, as assessed by study investigators based on comparing pre and post treatment photos.
Time frame: 8 weeks post final treatment
Number of patients with adverse events
Based on rate and severity of treatments with the PicoWay laser treatment
Time frame: Through study completion, average of 1 year
Investigator satisfaction with treatment
A 5-point satisfaction scale will be used by study investigators to assess satisfaction with treatment outcome
Time frame: 8 weeks post final treatment
Subject satisfaction with treatment
A 5-point satisfaction scale will be used by subjects to assess satisfaction with treatment outcome
Time frame: 8 weeks post final treatment
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