Evaluation of a Novel Microfocused Ultrasound with Three‐Dimensional Digital Imaging for Facial Tightening: A Prospective, Randomized, Controlled Trial

Background The excellent efficacy is mitigated by the limited safety profile of microfocused ultrasound procedures. Objective We sought to assess the safety and tightening efficacy of a novel microfocused ultrasound. Methods The randomized middle and lower face and submental region of the participants were treated with the novel device using the following transducers: M4.5, D4.5, M3.0, and D3.0. Improvement in paired comparison of pretreatment and posttreatment photographs, three-dimensional (3D) volumetric assessments, skin thickness measured by B-ultrasonography, and skin photoaging parameters were evaluated. Adverse events and patient satisfaction were also recorded. Results A total of 20 participants (20 female) were enrolled. Fourteen of 20 participants (70%) were judged to show clinically significant facial tightening during 3-month follow-up ( P < 0.05). The mean volumetric change in the lower face, as quantitatively assessed after 3 months was −0.29 mL compared with +0.42 mL on the control side ( P < 0.05). The VAS pain score was 3.00 ± 1.19 without any oral or intramuscular anesthesia. Conclusions A small sample size, lack of clinical scales, and impersonalized treatment parameters. The novel microfocused ultrasound appears to be a safe and effective modality for lower-face tightening. Clinical Trial Registration Number ChiCTR 2200064666.