Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Erythema index
研究概览
简要总结
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
详细描述
There are 106 healthy volunteers in this study. Upper left arm is divided into 2 parts (2x2 cm) which are A and B area. Upper right arm is divided into 2 parts (2x2 cm) which are C and D area. Four area (A, B, C, and D) are randomized to receive cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, and cream base (Control group). Samples are applied 2 times/day for 6 days (Induction phase). Then, the volunteers will stop applying samples for 7 to 10 days (Free period). After that, Samples are applied 2 times/day for 3 days (Challenge phase). Erythema, melanin, humidity, transepidermal water loss, skin adverse reaction, and satisfaction are evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 60 years
- •No skin diseases
- •No allergy to sericin and turmeric
- •No immunocompromised disease or using steroid for 2 weeks before participated in this study
- •Willing to participate in this study
排除标准
- •Uncontrolled disease, cancer, and heart disease
- •Cannot follow the protocol
- •Pregnancy and lactation
- •Participated in other studies
结局指标
主要结局
Erythema index
时间窗: 19 days
Measure by Cutometer. It represents inflammation. The value present in scale of erythema index (0 to 1000) (high value mean a worse outcome).
Melanin index
时间窗: 19 days
Measure by Cutometer. It represents post-inflammatory reaction. The value present in scale of melanin index (0 to 1000) (high value mean a worse outcome).
次要结局
- Transepidermal water loss index(19 days)
- Satisfaction of the volunteers(19 days)
- Skin reaction(19 days)
- Humidity index(19 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University