NCT03715049

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

Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response. Objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

Detailed description

To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period. This is a multi-site, non-randomized, non-controlled investigator initiated study designed to follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair treatment in the course of clinical practice.

Conditions

• Wrinkle

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2018-10-22
• Last updated: 2018-10-22

Locations

1 site across 1 country: United States