Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

NACompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Wrinkle
Interventions
PROCEDURE

Fraxel Laser Treatment

The device to be used in this study is a FDA approved device \[510(k) approval\] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 μm beam.

Trial Locations (1)

75390-9132

UT Southwestern Medical Center Dept. of Plastic Surgery, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Valeant Pharmaceuticals

INDUSTRY

lead

University of Texas Southwestern Medical Center

OTHER

NCT03715049 - Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles | Biotech Hunter | Biotech Hunter