Efficacy and safety of a noninvasive, home‐based radiofrequency device for facial rejuvenation: An open‐label, intraindividual controlled trial
Xuechen Ai, Liuyu Chen, Lan Yu, Ben Liu, Pengfei Song, Jing Wang, Zhenying Zhang
Abstract
BACKGROUND: Wrinkle formation is the most visible characteristic of facial aging. Radiofrequency (RF) technology is currently utilized to reduce facial wrinkles and contribute to skin rejuvenation. OBJECTIVE: To analyze the efficacy and safety of a noninvasive, home-based RF device applied for facial rejuvenation in Chinese people. METHODS: A single-center, open-label, intraindividual controlled trial was performed on subjects who received an 8-week treatment of the RF device. A total of 22 female individuals aged 25-60 years with Fitzpatrick skin type III-IV were enrolled. Efficacy of treatment was subjectively evaluated using the Fitzpatrick Wrinkle Classification Scale (FWCS) assessed by physician or overall satisfaction of subject with a 10-point VAS, and objectively using the skin ultrasound examination as well as the 3D skin analysis system. Adverse event was recorded at each visit. RESULTS: In comparison with the baseline, evaluator-assessed FWCS scores showed significant improvement at 4 weeks (p < 0.005) and 8 weeks (p < 0.005) after treatment. All subjects reported different degrees of improvement in facial wrinkles after 8 weeks of treatment. The results of skin ultrasound examination revealed significant increase of the dermal thickness at week 8 (p < 0.05) as compared to the baseline. In addition, a significant decrease in the proportion and density of perioral wrinkles evaluated by the 3D skin analysis system was observed from baseline to week 4. The treatment was well-tolerated, and no serious adverse event was observed. CONCLUSION: This noninvasive, home-based RF device was effective in improving skin texture and elasticity with a safe and well-tolerated treating procedure.