Clinical Efficacy and Safety of a Thermomechanical Fractional Injury Device for Neck Rejuvenation.

Abstract

BACKGROUND Neck rejuvenation has consistently become a popular cosmetic procedure. While various treatment modalities have been used, a novel fractional thermomechanical skin rejuvenation system was recently developed to create dermal coagulation through direct heat transfer with subsequent neocollagenesis. OBJECTIVE A prospective clinical trial evaluated the efficacy and safety of a thermomechanical fractional injury device (Tixel 2, Novoxel, Netanya, Israel) for neck rhytides. MATERIALS AND METHODS Subjects with moderate to severe neck rhytides were enrolled for 4 monthly treatments. RESULTS Twenty-six subjects were enrolled and completed all study visits. The mean age was 58.4 years, and 100.0% were women. Fitzpatrick skin types I to IV were included. For Fitzpatrick Wrinkle Classification System (FWCS), the mean baseline score was 6.3. As per investigator, there was a mean 1.5-grade improvement in FWCS at 1-month follow-up (p < .00001) and 1.4-grade improvement in FWCS at 3-month follow-up (p < .00001). For physician Global Aesthetic Improvement Scale, all subjects (100%) had improvement at both 1- and 3-month follow-up visits. There were no severe adverse events, and subjects experienced minimal pain. CONCLUSION A novel thermomechanical fractional injury device is effective and safe for the treatment of neck rhytides.