Temperature-Controlled Monopolar Radiofrequency in the Treatment of Submental Skin Laxity: A Prospective Study.

Background: Laxity of the submental area is a common cosmetic complaint of the aging population.

Objectives: The aim of this study was to determine the safety and effectiveness of a temperature-controlled, minimally invasive percutaneous monopolar radiofrequency device to improve dermal laxity and achieve lift.

Methods: A total of 72 subjects (35-65 years old) with mild to moderate skin laxity in the submental area were included in this single-center prospective study. All subjects received 1 treatment at baseline with an average subdermal temperature of 63°C. The primary endpoint was the proportion of subjects with at least a 20-mm2 decrease in surface area at Day 90 based on 3-dimensional photography. Secondary endpoints included skin elasticity measured by Cutometer, assessment by a blinded physician panel from 2-dimensional photographs, and physician- and subject-reported outcomes.

Results: At Day 90, 72.1% (95% CI: 62.2%-84.0%; P < 0.001) of subjects achieved at least a 20-mm2 lift of the submental area. All Cutometer-measured skin elasticity values (R2, R5, R7) showed significant improvement by 180 days. The independent panel graded 74.2% of subjects as "improved" at 90 days (95% CI: 62.0%-84.2%; P < 0.001). The treatment was well tolerated, and only 1 possibly related serious adverse event was reported (pharyngeal inflammation).

Conclusions: Treatment with temperature-controlled monopolar radiofrequency alone is a safe and effective treatment to achieve submental lift for at least 6 months.