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

ABSTRACT

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.