A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- TEWL score
研究概览
简要总结
This clinical study is conducted prospectively for 3 months after medical device treatment.
It is a comparative clinical study of the leading control group.
详细描述
Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study Perform a post-screening test.
Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria those who do not are registered for clinical research.
In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.
The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults over the age of 19
- •Subjects with partial layer skin transplantation
- •There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise
- •Decide to participate in this clinical study arbitrarily and in the written informed consent a person
排除标准
- •showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case
- •In situations where the requirements of a clinical study cannot be complied with
- •When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)
结局指标
主要结局
TEWL score
时间窗: Before, after one month after application, 3 month after application
Transepidermal water loss score/ No range of upper and lower score, the lower is best
次要结局
- Investigator Global Assessment scale(Before, after one month after application, 3 month after application)
- itching scale(Before, after one month after application, 3 month after application)
- Dermatology Life Quality Index(Before, after one month after application, 3 month after application)
- VSS(Before, after one month after application, 3 month after application)
研究者
Eun-ji Kim
Clinical Trial Manager
CGBio Inc.