NCT02600104

Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction

Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Unwanted Wrinkles

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-06-10
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-11-09
• Last updated: 2017-04-04

Locations

4 sites across 1 country: United States