Efficacy and Safety of Intelligent Microfocused Ultrasound in Lifting Facial Laxity: A Multicenter, Prospective, Randomized, Split‐Face Study
Shuzhan Shen, Jingjing Li, Qing Fan, Haiyan Zhang, Minzhi Wu, XueLei Li, Shuping Guo, Qian Yang, Chenchen Wang, Ling Ma, TianHua Xu, Xiuli Wang, Peiru WangABSTRACT
Background
Age‐related dermal collagen depletion compromises skin elasticity, manifesting as tissue laxity and loss of facial structural definition. The pursuit of facial tightening has driven vigorous development of non‐surgical rejuvenation modalities, with microfocused ultrasound emerging as a clinically validated intervention for restoring cutaneous firmness.
Objectives
This study aimed to assess the efficacy and safety of novel intelligent microfocused ultrasound (iMFU) in reversing facial aging and improving skin sagging.
Methods
Participants with facial aging and sagging were enrolled and iMFU treatment was performed on the randomized middle and lower hemiface. The length, angle, and area of the nasolabial folds and perioral wrinkles, the angle of the side face and the lower face, melanin index (MI), and erythema index (EI) were recorded and evaluated at 1st and 2nd month post‐treatment. Side effects and subjects' satisfaction scores were evaluated during treatment and each follow‐up visit.
Results
32 patients successfully completed the study. Quantitative analysis revealed obvious changes following iMFU treatment: the average length of perioral wrinkles and nasolabial folds on iMFU sides decreased by 7.2% ( p < 0.001) and 18.5% ( p = 0.011) in month‐2 follow‐up time. IMFU treatment also showed significant improvements in nasolabial fold angle (from 29.5 ± 4.3 to 30.7 ± 2.1) and area (37.5 ± 0.6 to 35.1 ± 1.2). Perioral folds achieved a similar therapeutic effect. Side face angle a demonstrated a significant increase from 12° ± 2.6° to 13° ± 1.5°, while the mandibular angle b similarly increased from 16° ± 2.4° to 18° ± 1.9° on iMFU sides. In addition, iMFU sides had greater benefits in improving MI and EI than the control sides. The subjects' satisfaction scores in iMFU sides were significantly higher than that in control sides. Except for 1 patient who experienced toothache after iMFU treatment, no persistent or serious side effects occurred in the other subjects.
Conclusion
IMFU treatment demonstrates both safety and efficacy for facial rejuvenation, with clinically validated outcomes in skin tightening, facial contour refinement, and skin tone improvement. This non‐invasive approach delivers significant aesthetic enhancement across multiple parameters of facial aging.