Safety and Efficacy of a Thermomechanical Fractional Injury Device for Periorbital Rhytides.

Abstract

Periorbital rejuvenation is a common cosmetic concern. A fractional thermomechanical skin rejuvenation system was developed to offer clinical improvements from direct heat transfer. A prospective study evaluated the efficacy and safety of the device for periorbital fine lines and wrinkles. Subjects with moderate-to-severe periorbital rhytides were enrolled and underwent 4 monthly treatments with a novel device using thermomechanical fractional injury (Tixel 2; Novoxel, Netanya, Israel). Fifty-one subjects were enrolled. Mean age was 56.8 years, and 88.2% were women. Fitzpatrick skin Types I to IV were included. For Fitzpatrick Wrinkle Classification System (FWCS), mean baseline score was 5.7. Per investigator, there was a mean 2.0-grade improvement in FWCS at 3-month follow-up ( p < .0001). Per 3 blinded physician raters, there was a mean improvement of 2.2 ( p < .0001), 2.0 ( p < .0001), and 1.2 ( p < .0001) in FWCS at 3-month follow-up. Each of the raters correctly identified posttreatment images for 87.5%, 77.1%, and 75.0% of subjects. At least 2 raters agreed on grading 83.3% of subjects as responders. There were no severe adverse events. Subjects experienced minimal pain and downtime. A novel device using thermomechanical fractional injury was demonstrated to be safe and effective in the treatment of periorbital rhytides.