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临床试验/NCT04182542
NCT04182542已完成不适用

Effects of Capacitive Radiofrequency at the Dermis and Adipose Tissue in the Abdominal Region

Escola Superior de Tecnologia da Saúde do Porto1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole

研究概览

简要总结

Noninvasive fat reduction is a rapidly expanding field of cosmetic rejuvenation, as many patients are unwilling to suffer the downtime and healing associated with traditional invasive liposuction. The radiofrequency (RF) device has been shown to be safe and effective for non-invasive fat reduction, as well as cutaneous enhancement and improvement of skin flaccidity (BOISNIC, et al., 2014).

详细描述

In Brazil, the search for satisfaction with self-image has been increasing, since the profile of the population has been altered by cultural factors such as industrialized foods with high caloric content and sedentary lifestyle. These factors result in the accumulation of adipose tissue in typical and atypical places, caused by the imbalance of the energy balance, that is, a higher caloric intake when compared to the energy consumption.

Noninvasive fat reduction is a rapidly expanding field of cosmetic rejuvenation, as many patients are unwilling to suffer the downtime and healing associated with traditional invasive liposuction. The radiofrequency (RF) device has been shown to be safe and effective for non-invasive fat reduction, as well as cutaneous enhancement and improvement of skin flaccidity (BOISNIC, et al., 2014).

Radiofrequency emits focused electromagnetic waves that find resistance in the tissue, generating heat (KRUEGUER, LEVY and SADICK, 2012). This thermal energy affects the triple helix structure of the collagen, subsequently breaking the intramolecular hydrogen bonds, resulting in immediate contraction of the collagen and neocollagenesis in the dermis, without interfering in the epidermis.

This neocollagenesis and remodeling of collagen results in a visibly compacted and organized dermis. Skin enhancement is an important effect, since patients that search for non-invasive fat reduction usually also seek improvement in skin flaccidity. This represents a substantial improvement over currently available technology (BOISNIC, et al, 2014).

There is controversy regarding the mechanism of fat mobilization. Some authors, after observing human skin cultures at the end of the series of RF treatments found a profound effect on subcutaneous adipocytes. The analysis resulted in altered morphology and increased expression of the pyroptosis marker, APAF-1, suggesting that pyroptosis induced by irreversible electroporation is the mechanism of action. Adipocyte pyroptosis results in the release of triglycerides from disintegrated cell membranes, but in a delayed and gradual manner, allowing a slow and safe removal through the interstitial space and liquid transport systems, lymphatic vessels and other metabolic functions. There was no evidence of necrosis or inflammatory changes observed in adipocytes after treatments with BodyFX, a type of radiofrequency (BOISNIC, et al, 2014).

研究设计

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

盲法说明

The assessor will not know, when analyzing the samples, to which group they belong.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who will undergo plastic abdominoplasty surgery at the Clinical Hospital of the Federal UFTM.

排除标准

  • Sensitive and cognitive deficits
  • Aged less than 18 years
  • Metal implant at the application site
  • Pacemakers
  • Signs of infection
  • Circulatory disorders
  • Neoplasia.

结局指标

主要结局

percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole

时间窗: 30 days

The percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole will be marked by the Image J® program and registered in a Microsoft Excel worksheet- For the variables percentage of collagen, elastic fibers, number of fibroblasts and number of adipocytes will be performed the normality test with Shapiro Wilk. The paired t test will be used when data are normal and Wilcoxon when not normal. The differences observed will be considered significant when the probability of rejection of the null hypothesis is less than 0.05.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreia Noites

Professor/Investigator

Escola Superior de Tecnologia da Saúde do Porto

研究点 (1)

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