Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Patients Under Radiotherapy After Breast Tumor Resection
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
- 2
- 主要终点
- Transepidermal water loss
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
Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion.
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.
- Control group: Physiogel Skin Stability Intensive Cream MD (10 people)
- Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are randomly assigned in a 2:1 ratio between the study group and the control group.
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
- 否
入选标准
- •adults over the age of 19
- •The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation
- •Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom
排除标准
- •When participating in a clinical study, the findings of radiation dermatitis in the area are shown
- •A person who shows signs of acute or chronic dermatological diseases
- •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
Transepidermal water loss
时间窗: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Percutaneous moisture loss measured
次要结局
- VSS(Before, after one month after application, 3 month after application)
- Itching score(Before, after one month after application, 3 month after application)
- BREAST-Q Survey Assessment(Before, after one month after application, 3 month after application)
研究者
Eun-ji Kim
Clinical Trial Manager
CGBio Inc.