Goldberg David J
Division of Schweiger Dermatology, New York, NY, USA.
J Cosmet Dermatol. 2025 Jan;24(1):e16643. doi: 10.1111/jocd.16643. Epub 2024 Nov 13.
Submental fullness is perceived as unattractive by both men and women. The noninvasive simultaneous delivery of HIFES and synchronized radiofrequency+ (Sync RF+) technologies aims to address the submental fullness by concurrently targeting the skin, adipose tissue, and weakened anterior belly of the digastric muscle, the three contributing layers to the double chin appearance.
This study aims to investigate the histological changes to adipose tissue related to cell morphology, caspase-7, and Bcl-2 levels to detect adipocyte apoptosis following the HIFES and Sync RF+ treatment on human subjects.
The active group (n = 6) received single 20-min treatment on the submental area, while the control group (n = 2) did not receive any treatment. Biopsies of subcutaneous fat tissue were obtained at baseline, and 24 h and 7 days posttreatment. The specimens were histologically and immunohistochemically analyzed for changes in morphology, caspase-7, and Bcl-2 levels.
Observed caspase-7 levels increased by 511% at 24-h posttreatment, and 101% at 7 days (p < 0.0001), while the Bcl-2 levels decreased by 89% at 24 h and 24% at 7 days posttreatment (p < 0.0001). The control group had no statistically significant relative changes in the activity of caspase-7. Posttreatment adipocytes were shrunken in size, and shapes lost their uniformity compared to baseline. Five of six subjects reported the treatment as being comfortable. No adverse events were observed during the study.
The results of this human histology study indicate that noninvasive HIFES and Sync RF+ technologies have a favorable safety profile for submental fat reduction through the induction of adipocyte apoptosis.
ClinicalTrials.gov identifier: NCT06282172.
颏下丰满被男性和女性都视为缺乏吸引力。高能量聚焦超声（HIFES）与同步射频+（Sync RF+）技术的非侵入性同步应用旨在通过同时针对皮肤、脂肪组织和弱化的二腹肌前腹（形成双下巴外观的三个相关层次）来解决颏下丰满问题。
本研究旨在调查在人类受试者中，经HIFES和Sync RF+治疗后，与细胞形态、半胱天冬酶-7（caspase-7）和Bcl-2水平相关的脂肪组织的组织学变化，以检测脂肪细胞凋亡情况。
治疗组（n = 6）在颏下区域接受单次20分钟的治疗，而对照组（n = 2）未接受任何治疗。在基线、治疗后24小时和7天获取皮下脂肪组织活检样本。对样本进行组织学和免疫组织化学分析，以观察形态、caspase-7和Bcl-2水平的变化。
观察到治疗后24小时caspase-7水平增加了511%，7天时增加了101%（p < 0.0001），而治疗后24小时Bcl-2水平下降了89%，7天时下降了24%（p < 0.0001）。对照组caspase-7活性无统计学意义的相对变化。与基线相比，治疗后的脂肪细胞体积缩小，形状失去均匀性。六名受试者中有五名报告治疗过程舒适。研究期间未观察到不良事件。
这项人体组织学研究结果表明，非侵入性HIFES和Sync RF+技术通过诱导脂肪细胞凋亡来减少颏下脂肪，具有良好的安全性。
ClinicalTrials.gov标识符：NCT06282172。
