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微绝缘针状射频设备减少颏下脂肪的疗效和安全性

Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat.

作者信息

Kim Bo Ri, Kim Minjae, Kim Jee Woo, Shin Jung-Won, Na Jung-Im, Huh Chang-Hun

机构信息

Department of Dermatology, Seoul National University Bundang Hospital, Seongnam; and.

Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Dermatol Surg. 2023 Apr 1;49(4):389-394. doi: 10.1097/DSS.0000000000003723. Epub 2023 Feb 10.

DOI:10.1097/DSS.0000000000003723
PMID:36799883
Abstract

BACKGROUND

Recently, it has been reported that a micro-insulated needle radiofrequency (RF) system is effective at achieving subcutaneous fat reduction; however, no study has yet applied this technique to reduce submental fat.

OBJECTIVE

To evaluate the efficacy and safety of a fractional RF device with a micro-insulated needle to reduce submental fat.

MATERIALS AND METHODS

In this prospective, single-blinded, pre-post comparative study, 24 adults with excess submental fat were treated once using a micro-insulated needle RF device. Outcomes included efficacy (submental fat rating by an independent investigator, fat volume quantified with a 3-dimensional camera, and patient satisfaction), assessed 1 and 2 months after the procedure, and safety (adverse events), assessed throughout the study.

RESULTS

The patients' Physician-Assisted Submental Fat Rating Scale score significantly decreased after 1 month and further decreased after 2 months. The average volume of submental fat was significantly decreased after 2 months (20.44 ± 5.53 cc to 16.41 ± 4.58 cc, p < .001). Patient satisfaction was high. Transient and mild local skin reactions without long-term sequelae were observed in 4 patients.

CONCLUSION

The micro-insulated needle RF device is beneficial for the reduction of submental fat and has tolerable safety profiles.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05517824.

摘要

背景

最近,有报道称微绝缘针射频(RF)系统在减少皮下脂肪方面有效;然而,尚未有研究将该技术应用于减少颏下脂肪。

目的

评估一种带有微绝缘针的分次射频设备减少颏下脂肪的疗效和安全性。

材料与方法

在这项前瞻性、单盲、前后对比研究中,24名有颏下脂肪过多的成年人使用微绝缘针射频设备进行了一次治疗。结果包括疗效(由独立研究者进行颏下脂肪评级、用三维相机量化脂肪体积以及患者满意度),在治疗后1个月和2个月进行评估,以及安全性(不良事件),在整个研究过程中进行评估。

结果

患者的医师辅助颏下脂肪评级量表评分在1个月后显著降低,在2个月后进一步降低。2个月后颏下脂肪的平均体积显著减少(从20.44±5.53立方厘米降至16.41±4.58立方厘米,p<.001)。患者满意度较高。4名患者出现了短暂且轻微的局部皮肤反应,无长期后遗症。

结论

微绝缘针射频设备对减少颏下脂肪有益,且具有可耐受的安全性。

试验注册

ClinicalTrials.gov标识符:NCT05517824。

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