Long-Term Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Skin Tightening: A Prospective Randomized Controlled Study.

Objectives: To evaluate the efficacy and safety of a novel monopolar RF device for skin tightening and rejuvenation treatment.

Methods: Forty participants were enrolled in the study. Subjects randomized to the treatment group received a single treatment with the novel RF device (YOUMAGIC), whereas the control group received regular RF treatment (Thermage CPT; Solta Medical). Digital photographs and Antera 3D photographs were taken at baseline, 1-, 3-, and 6-month posttreatment. The depression volume of nasolabial folds (NLFs) in each visit was evaluated using the Antera 3D imaging program. The pain was evaluated by pain measurement scales immediately after treatment. Any procedure-related side effects were documented and examined.

Results: Posttreatment results were compared with the baseline; statistically significant mean depression volume (MDV) changes of NLFs were found at 1, 3, and 6 months posttreatment. No significant MDV changes were found between the treatment and control groups. No severe adverse events were reported.

Conclusions: Our study demonstrates that the novel monopolar RF device is clinically safe and effective for skin tightening in the lower face area, and is not inferior to the regular RF therapeutic device.