Clinical Trial to Assess the Efficacy and Safety of Neopop-S Containing EASYDEW
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Transepidermal water loss Transcutaneous water loss (TEWL) measured
研究概览
简要总结
The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.
详细描述
This clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research.
The subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study.
The screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research.
Participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio.
- Control group: 10 people without treatment
- Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are randomly assigned to control and study groups. In the case of the study group, the Easy Dew Regen MD cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. The control group is the non-chalant group. However, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues
- •Decided to participate in this clinical study and signed a written informed consent the subject
排除标准
- •Subjects with uncontrolled diabetes
- •Subjects with uncontrolled hypertension and cardiovascular disease
- •Subjects with hemorrhagic diseases such as hemophilia
- •Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results Subjects who are or are scheduled to receive medication for an extended period of time
- •Acute or chronic skin disease causes stage progression or active bacteria in the application area Who has a virus infection
- •When the researcher's judgment determines that participation in the study is inappropriate (e.g. keloid constitution)
结局指标
主要结局
Transepidermal water loss Transcutaneous water loss (TEWL) measured
时间窗: Before, immediately after treatment, and one month after application
Before, immediately after treatment, and one month after application of the medical device Transcutaneous water loss (TEWL) measured
次要结局
未报告次要终点
研究者
Eun-ji Kim
Clinical Trial Manager
CGBio Inc.