Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
The PicoWay base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier.
Dr. Jerome M. Garden
Chicago, Illinois, United States
New York Laser & Skin Care
New York, New York, United States
Dr. Eric F. Bernstein
Ardmore, Pennsylvania, United States
Efficacy of the PicoWayTM treatment
assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.
Time frame: from day 0 up to 13 months
Safety of the PicoWayTM
assessed by study investigator during all study visits (treatments and follow-up).
Time frame: from day 0 up to 13 months
efficacy of the PicoWayTM fractional treatment by the investigator
assessed by study investigator during all study visits (starting from the second treatment).
Time frame: after 3 weeks up to 13 months
Evaluate investigator satisfaction post treatments
assessed by investigator satisfaction post treatments
Time frame: after 46 weeks and after 52 weeks
subject satisfaction post treatments
assessed by subject satisfaction post treatments.
Time frame: after 46 weeks and after 52 weeks
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