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临床试验/NCT03397758
NCT03397758已完成不适用

Non-surgical Treatment for Eye Bag Using AGNES(Radiofrequency Device) With Micro-insulated Needle

Seoul National University Hospital0 个研究点目标入组 24 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
The changes of height of fat bulging

研究概览

简要总结

The investigators treated twenty-four subjects with lower eyelid fat bulging using the needle radiofrequency system. After treatment, a three-dimensional photogrammetry system was used to objectively measure the change in height of the fat bulge.

详细描述

Materials and Methods

Subjects

Twenty-four volunteers (4 males and 20 females) with lower eyelid fat bulging were enrolled in this study. The average age of these subjects was 56±6.28 years. The exclusion criteria were as follows: Prior cosmetic facial surgery within the past 1 year, placement of tissue fillers within the last 6 months, laser therapy or chemical peeling of midface within the preceding 3 months, and the use of topical retinoids for the face within the past 1 month. The study protocol was approved by the institutional review board Seoul National University Bundang Hospital and informed consent was obtained from all subjects prior to participation.

Treatment protocol

All treatments were performed under local anesthesia with 1% lidocaine and 1:100,000 epinephrine. To minimize the impact on the treatment area, the least amount of anesthesia required was injected. The amount of AGNES micro-insulated needles with radiofrequency applicators (Gowoonsesang Cosmetics Co, Seongnam, Gyeonggi, Korea) were used to treat the lesions. This device is a monopolar radiofrequency system with 1MHz wavelength. The needles were composed of two parts: The proximal insulated area and the distal non-insulated area. Proximal insulation preserves the epidermis from thermal damage, allowing the procedure to be non-ablative and minimally-invasive.

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
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adult with age of 40s or more
  • •Who has lower eyelid fat bulging

排除标准

  • •History of keloid or hypertrophic scar
  • •Pregnant woman,
  • •On breast feeding
  • •Active skin disease on lesional skin
  • •Who has severe allergy
  • •History of bleeding disorder

研究组 & 干预措施

Study population

Experimental

They were treated with AGNES micro-insulated needles with RF applicators in two separate sessions, at intervals of four weeks.

干预措施: Study population (Device)

结局指标

主要结局

The changes of height of fat bulging

时间窗: up to 24weeks

To height of fat bulging was determined as an arbitrary reference plane that links the three points: two points where the right and the left mid pupillary lines meet at each lower eyelid, and the other one point at the pogonion (the most anterior part on the chin). Then, the distance from this reference plane to the highest point of fat bulging was defined as the height of fat bulging.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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