The Efficacy of Energy‐Based Devices of Radiofrequency With Low Frequency on Facial Aging: A Single‐Arm Clinical Trial

Background Facial aging is caused by structural and functional degeneration and atrophy of multiple layers including skin, fat, muscle, and bone. Energy‐based device (EBD) therapy has been primarily utilized for strengthening muscle, as well as ameliorating the sagging and laxity of skin in the entire body. Hence, the appropriate EBD‐induced strength of facial muscles might help improve facial rejuvenation. Objectives To evaluate the efficacy and safety of facial rejuvenation by EBD of radiofrequency (RF) with low frequency (LF). Methods Participants aged 36–70 years with any Fitzpatrick Wrinkle Scale (FWS) score of 2 or higher were invited to the study and received EBD treatment. The primary outcome was the decline of FWS score and machine learning model inferred apparent age (MAA). The differences across age stratifications and the differences across facial regions represented the second outcomes. Results A total of 30 participants were included. Firstly, using a contemporaneous retrospective untreated comparator, the overall variation (baseline–follow‐up) in FWS was −0.03 (−0.119 to 0.050 to, ns) in the untreated cohort vs 0.17 (0.083–0.253, ∗∗∗ ) in the EBD cohort. For MAA, variations were −0.77 (−1.453 to −0.093, ns) vs 0.66 (−0.270 to 1.595, ∗ ), respectively. Thus, EBD showed greater improvement than the retrospective untreated comparator for both endpoints. Secondly, in age stratification and facial region analysis, there were significant statistical differences between the mild and severe laxity stratifications and between periocular and nasolabial regions. Furthermore, the EBD‐induced mid‐to‐upper facial lifting showed differences between the severe laxity stratification and mild laxity stratification, whereas no obvious volume variance of facial soft tissue was observed after treatment. The average visual analog scale (VAS) score was 0.167 (indicating mild and acceptable pain), and patient satisfaction was 86.67%. Adverse events were mainly mild, including slight pain sensation around the dental nerve in four cases (13.33%), as well as transient rash on the cheeks in one case (3.33%). Conclusions The results show that EBD therapy might safely and effectively improve facial aging. This technique appears to offer better facial rejuvenation outcomes for older individuals or those with severe mid‐to‐upper facial aging. Larger randomized clinical trials are needed to confirm this finding. Trail Registration : China Clinical Trial Registration Center: ChiCTR2300077485