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.
BACKGROUND: ChiCTR 2200064666.
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.
BACKGROUND: ChiCTR 2200064666.
摘要：
背景：微聚焦超声程序的有限安全性减轻了出色的功效。
目的：我们试图评估一种新型微聚焦超声的安全性和紧缩效果。
方法：使用以下传感器对参与者的随机中下面部和下面部进行治疗：M4.5，D4.5，M3.0和D3.0。改进预处理和后处理照片的成对比较，三维(3D)体积评估，通过B超测量皮肤厚度，和皮肤光老化参数进行了评估。记录不良事件和患者满意度。
结果：共纳入20名参与者（20名女性）。在3个月的随访中，20名参与者中有14名（70％）被认为表现出临床上明显的面部收紧（P<0.05）。下表面的平均体积变化，3个月后定量评估为-0.29mL，而对照组为+0.42mL（P<0.05）。在没有任何口服或肌内麻醉的情况下，VAS疼痛评分为3.00±1.19。
结论：样本量小，缺乏临床量表，和非个性化治疗参数。新型微聚焦超声似乎是下面部收紧的安全有效方式。
背景：ChiCTR2200064666。
目的：我们试图评估一种新型微聚焦超声的安全性和紧缩效果。
方法：使用以下传感器对参与者的随机中下面部和下面部进行治疗：M4.5，D4.5，M3.0和D3.0。改进预处理和后处理照片的成对比较，三维(3D)体积评估，通过B超测量皮肤厚度，和皮肤光老化参数进行了评估。记录不良事件和患者满意度。
结果：共纳入20名参与者（20名女性）。在3个月的随访中，20名参与者中有14名（70％）被认为表现出临床上明显的面部收紧（P<0.05）。下表面的平均体积变化，3个月后定量评估为-0.29mL，而对照组为+0.42mL（P<0.05）。在没有任何口服或肌内麻醉的情况下，VAS疼痛评分为3.00±1.19。
结论：样本量小，缺乏临床量表，和非个性化治疗参数。新型微聚焦超声似乎是下面部收紧的安全有效方式。
背景：ChiCTR2200064666。
