35 kDa 透明质酸片段 (HA35) 注射液治疗皮肤问题的临床疗效和安全性。
美容皮肤病学和慢性皮肤炎症
To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ulaanbaatar、蒙古
- Nahia Impex LLC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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。
Exclusion Criteria:
- Pregnant or lactating women.
- Suffering from psychological or mental illness.
- Life is not regular, overeating.
- Hypersensitive to hyaluronic acid, and has a scar constitution.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：DermaShine PRO负微针仪
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First, apply an appropriate amount of compound lidocaine cream to the treatment site ( national drug approval number H20063466 ; Beijing Ziguang Pharmaceutical Co., Ltd. ) waited for 60 minutes after applying hemp, and then injected the syringe containing sterile HA35 prepared in advance into the subcutaneous 1.0-1.5mm through the DermaShine PRO negative pressure microneedle importer ( Demasha, South Korea ).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
A skin dryness scale
大体时间：120 minutes and 960 minutes
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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. |
120 minutes and 960 minutes
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A fair or smooth skin scale
大体时间：120 minutes and 960 minutes
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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. |
120 minutes and 960 minutes
|
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A skin pore size scale
大体时间：120 minutes and 960 minutes
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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. |
120 minutes and 960 minutes
|
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A inflammatory skin thick hardness scale
大体时间：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. |
120 minutes and 960 minutes
|
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An erythema color and area scale
大体时间：120 minutes and 960 minutes
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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. |
120 minutes and 960 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-satisfaction evaluation
大体时间：1 week after the end of the treatment
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One week after the end of the treatment, a return visit was conducted to collect the overall satisfaction score of the subjects on the skin treatment. Using the questionnaire (0-10 score) to assess this outcome measure. 0 represents the most dissatisfied, while 10 represents the most satisfied. |
1 week after the end of the treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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