A Single Center, Randomized, Double-blind and Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
研究概览
简要总结
This is a single center, randomized, double-blind and placebo controlled clinical study to evaluate the efficacy and safety of brightening microneedle patch on facial solar lentigines. Subjects who are 30 to 65-year-old with solar lentigines on their faces will receive brightening microneedle patches on facial solar lentigines once a day for 4 weeks. Afterwards, facial images and skin detectors will be used to analysis their skin, according to various skin tone indexes and skin response score sheets.
详细描述
Method: 35 subjects, Fitzpatrick Skin Type II to IV. Each subject has at least two brown solar lentigines on the face, and the two spots are independent, each with a clear boundary and diameter ≥ 0.5 cm.
This trial includes 1 screening visit (Day -1), wash-out period (2 weeks before the trial), trial period (4 weeks in total), and 3 return visits for detecting (baseline detecting at the end of the wash-out period, the 2nd week and the 4th week of the trial period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
时间窗: 4 week
measure L\* (luminance) and b\* (yellow/blue component) values at baseline and 4th week by color meter (CR-400 Chroma Meter) to assess the ITA° percentage change. (ITA°=tangent arc((L\*-50)/b\*) 180/3.14159)
次要结局
- the value change of skin tone index ITA° value of facial solar lentigines from baseline(2 week)
- the value change of melanin index of facial solar lentigines from baseline(4 week)
- the percentage change of melanin index of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by skin response(through study completion, an average of 4 weeks)
- rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system(4 week)
- assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by adverse reactions(through study completion, an average of 4 weeks)
- assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by subject diary(through study completion, an average of 4 weeks)
- assessing the subjects' compliance with the trial by subjects' return visits(through study completion, an average of 4 weeks)
- assessing the subjects' compliance with the trial by subject diary(through study completion, an average of 4 weeks)
- assessing the subjects' compliance with the trial by the number of patches packages returned(through study completion, an average of 4 weeks)
- assessing the subjects' feedback of the patches(through study completion, an average of 4 weeks)