Efficacy and safety of a noninvasive, home-based radiofrequency device for facial rejuvenation: An open-label, intraindividual controlled trial

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.