Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply on healthy human all skin types.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of subjects that showed No significant irritation.
研究概览
简要总结
Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends 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 supportive reaction without the involvement of the immune system. In this patch test the irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men and women ration of 1:1 between 18 and 65 years.
- •2.Having healthy skin on test area as assessed by dermatological examination.
- •3.For whom the investigator considers that the compliance will be correct.
- •4.Subjects with normal, dry, oily and combination skin.
排除标准
- •1.Pregnant/nursing mothers.
- •2.Scars, excessive terminal hair, or tattoo on the studied area.
- •3.Dermatological infection/pathology on level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
结局指标
主要结局
Number of subjects that showed No significant irritation.
时间窗: Day 1, Day 2, Day 3, Day 8
Score of less than or equal to 2 on the Draize scale.
时间窗: Day 1, Day 2, Day 3, Day 8
次要结局
- NA(NA)