CTRI/2012/09/002963已完成不适用
Single application closed patch test to evaluate the safety of skin care formulations on healthy human subjects representing varied skin type.
Wipro Limited consumer care lighting division1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年8月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- irritation potential
研究概览
简要总结
Skin Irritation Test:
Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test.
研究设计
- 研究类型
- Interventional
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Is a female/ male in generally good health,Is between the ages of 18 and 50 years,Has not participated in a similar clinical investigation in the past four weeks,Is willing to give a written informed consent and come for regular observation.
排除标准
- •A known history or present condition of allergic response to any cosmetic products,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,Medications (e.g. steroids or antihistamines), which would compromise the study.
结局指标
主要结局
irritation potential
时间窗: 0hrs, 24 hrs and 1 week after patch removal
次要结局
- Investigational products to be tested for irritancy test(On each subject’s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).)
研究者
研究点 (1)
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