跳至主要内容
临床试验/NCT02512822
NCT02512822已完成不适用

Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Kangbuk Samsung Hospital0 个研究点目标入组 21 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
主要终点
Change from Baseline in thickness of the submental fat at 6 months

研究概览

简要总结

To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

详细描述

Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis.

Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinically appreciable localized excess of subcutaneous fat on the submental area
  • no history of systemic underlying disease

排除标准

  • any infectious or inflammatory skin diseases
  • psychiatric patients
  • systemic underlying disease
  • who had taken aesthetic procedure on the face, before 6-month
  • more than 5% weight change were dropped out.

结局指标

主要结局

Change from Baseline in thickness of the submental fat at 6 months

时间窗: 6 months

thickness of the submental fat measured by ultrasound

Change from Baseline in submental circumference at 6 months

时间窗: 6 months

thickness of the submental fat measured by a tape measure

次要结局

  • participants' assessment for improvement at 6 months(6 months)
  • participants' assessment for satisfaction at 6 months(6 months)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Won-Serk Kim

Associate professor

Kangbuk Samsung Hospital

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