NCT02592993

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

Type	Name	Description
DEVICE	PicoWay device	The PicoWay 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: 2015-05-23
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2015-10-30
• Last updated: 2017-02-23

Locations

3 sites across 1 country: United States