An interventional study of PicoWayTM in Unwanted Wrinkles, sponsored by Syneron Medical. Status unknown at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment
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.
Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: PicoWayTM
The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier
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
Plan to share: Undecided
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Syneron Medical