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Safety and Efficacy of a Thermomechanical Fractional Injury Device for Periorbital Rhytides.
- Source :
-
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2023 Apr 01; Vol. 49 (4), pp. 374-377. Date of Electronic Publication: 2023 Feb 22. - Publication Year :
- 2023
-
Abstract
- Background: Periorbital rejuvenation is a common cosmetic concern. A fractional thermomechanical skin rejuvenation system was developed to offer clinical improvements from direct heat transfer.<br />Objective: A prospective study evaluated the efficacy and safety of the device for periorbital fine lines and wrinkles.<br />Materials and Methods: 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).<br />Results: 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.<br />Conclusion: A novel device using thermomechanical fractional injury was demonstrated to be safe and effective in the treatment of periorbital rhytides.<br /> (Copyright © 2023 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)
Details
- Language :
- English
- ISSN :
- 1524-4725
- Volume :
- 49
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
- Publication Type :
- Academic Journal
- Accession number :
- 36826343
- Full Text :
- https://doi.org/10.1097/DSS.0000000000003728