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

BACKGROUNDPeriorbital rejuvenation is a common cosmetic concern. A fractional thermomechanical skin rejuvenation system was developed to offer clinical improvements from direct heat transfer.OBJECTIVEA prospective study evaluated the efficacy and safety of the device for periorbital fine lines and wrinkles.MATERIALS AND METHODSSubjects 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).RESULTSFifty-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.CONCLUSIONA novel device using thermomechanical fractional injury was demonstrated to be safe and effective in the treatment of periorbital rhytides.