Efficacy and safety of a novel monopolar radiofrequency device for skin tightening: a multicenter, randomized, 6-month, assessor blind, positive parallel-controlled, non-inferiority trial

Skin laxity and static wrinkles cause aesthetic concerns. Monopolar radiofrequency (RF) could produce measurable improvement. This study aims to evaluate the efficacy and safety of a novel monopolar RF device, YOUMAGIC, for skin tightening and rejuvenation treatment. In this multicenter, 6-month, assessor blind, positive parallel-controlled study, subjects were randomized to receive a single treatment with YOUMAGIC or Thermage (CPT; Solta Medical). Efficacy was mainly determined by the effective rate of facial wrinkle improvement [Global Aesthetic Improvement Scale (GAIS)] 90 days after treatment. Safety assessments were conducted through structured inquiries, adverse event diaries maintained by subjects, laboratory tests, and monitoring of vital signs. Of the 230 enrolled subjects, 212 were included in the final analysis. The proportions of subjects who achieved ≤ 3-grade on the GAIS were 100% in the treatment group and 98.10% in the control group 90 days after treatment. No significant differences were found between the treatment and control groups. No subjects experienced any serious adverse events. In conclusion, the novel monopolar RF device YOUMAGIC is clinically safe and effective for skin tightening and is not inferior to the regular RF therapeutic device.Clinical trial registry identifier: ChiCTR2400087993. URL: https://www.chictr.org.cn/showproj.html?proj=225518 2024-08-08 retrospectively registered.