Title : Clinical efficacy and safety of a novel microfocused ultrasound for facial rejuvenation: a prospective study
Abstract:
Introduction: The novel microfocused ultrasound has become a popular approach for tightening the sagging of fat pad-induced laxity in China. Nevertheless, robust evidence, particularly the histological studies supporting the rejuvenative effects, is lacking.
Objective: This study aims to examine the efficacy and safety of the novel microfocused ultrasound in the facial rejuvenation .
Methods: The study enrolled 20 participants (18 females and 2 males), treated with the novel device using the transducers M4.5, D4.5, M3.0, and D3.0. The followings were used for the assessments: Fitzpatrick Wrinkle Classification System (FWCS), Global Aesthetic Improvement Scale (GAIS), and patient satisfaction. Adverse events were recorded alongside with patient satisfaction.
Results: All 20 patients completed the 3-month follow-up. Fitzpatrick wrinkle and elasticity scores decreased from baseline (5.5±0.89; 4.85±0.81) to 1-month (4.65±1.09; 4.15±0.81) and 3-month post-treatment (4.55±1.00; 3.95 ±0.61) with a significant difference (p<0.001). For GAIS, all subjects demonstrated clinical improvement. Histopathological analysis showed no significant epidermal changes; however, elastic fiber disruption/thickening, fat layer thinning, and reduced adipocyte counts in the dermis/subcutis were observed at 1-month post-treatment compared to the baseline. No serious or unanticipated adverse events were found.
Conclusions: The novel microfocused ultrasound is a safe and effective modality for the facial rejuvenation and tightening.
