Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.
This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for 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
74
The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier
Jerome M. Garden
Chicago, Illinois, United States
Arielle N. Kauvar
New York, New York, United States
Eric F. Bernstein
Ardmore, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis.
assessed by blinded evaluators.
Time frame: day 0 up to 9 months
Improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator
Percentage of subjects with improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator
Time frame: from 3 weeks up to 9 months
Safety of PicoWay treatment by Adverse events record during all study
assessed by study investigator during all study
Time frame: day 0 up to 9 months
Evaluate investigator satisfaction assessed by questionnaire
by questionnaire
Time frame: from 24 weeks up to 36 weeks
Evaluate subject satisfaction assessed by questionnaire
by questionnaire
Time frame: from 24 weeks up to 36 weeks
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