35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A inflammatory skin thick hardness scale
研究概览
简要总结
To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skin problems include but are not limited to dry skin, dark skin, and coarse pores.
- •Chronic skin inflammation, pigmentation, erythema, etc.
- •Cooperate with the experimental requirements and be able to complete the score independently。
排除标准
- •Pregnant or lactating women.
- •Suffering from psychological or mental illness.
- •Life is not regular, overeating.
- •Hypersensitive to hyaluronic acid, and has a scar constitution.
研究组 & 干预措施
DermaShine PRO negative microneedles instrument
干预措施: 35 kDa hyaluronan fragment HA35 injection (Drug)
结局指标
主要结局
A inflammatory skin thick hardness scale
时间窗: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of inflammatory skin thick hardness, while 10 represents the worst degree of inflammatory skin thick hardness.
A skin dryness scale
时间窗: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents no skin dryness, while 10 represents the worst degree of skin dryness.
A fair or smooth skin scale
时间窗: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the worse degree of fair or smooth skin, while 10 represents the best degree of fair or smooth skin.
A skin pore size scale
时间窗: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of skin pore size, while 10 represents the worst degree of skin pore size.
An erythema color and area scale
时间窗: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of erythema color and area, while 10 represents the worst degree of erythema color and area scale.
次要结局
- Self-satisfaction evaluation(1 week after the end of the treatment)