“Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of application on healthy human all skin typesâ€.
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
- 2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale.
研究概览
简要总结
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans. Sample Size: Twenty-four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 35 years to 65 years (both inclusive) Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance. By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs. and is done as per BIS standard (BIS4011:2018).
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
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
- •2.Healthy Men & women volunteers are chosen in ratio of 1:1 aged > 35 and < 60 years.
- •3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.
排除标准
- •1.Pregnant/nursing mothers.
- •2.Scars, excessive terminal hair, or tattoos on the studied area.
- •3.Dermatological infection/pathology on level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Chronic illness which may influence the outcome of the study.
结局指标
主要结局
2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale.
时间窗: Baseline,Day1, Day 2, Day 3, Day 7
次要结局
- NA(NA)