Evaluation of Dermatological safety of Test products by primary irritation patch test on healthy human volunteers of varied skin types
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
- Safety assessment of investigational products for
研究概览
简要总结
Objective: 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 18 years to 45 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
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects in the age group of 18-45 years (both age inclusive)
- •Subjects with Fitzpatrick skin type III to V
- •Subjects willing to give a voluntary written informed consent
- •Subjects having not participated in a similar investigation in the past two weeks
- •Subjects willing to come for regular follow up visits
- •Subjects without any open wounds, cuts, abrasions, irritation symptoms.
排除标准
- •Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application
- •Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results
- •Subject is Pregnant or Lactating
- •Athletes and subjects with a history of excessive sweating
- •Subjects on an oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results
- •Subjects participating in any other cosmetic or therapeutic trial
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease, or history of alcoholism, HIV, or any other serious medical illness.
结局指标
主要结局
Safety assessment of investigational products for
时间窗: Safety assessment of investigational products for irritation potential using draize scale.
irritation potential using Draize scale at 0 hour, 24 hours and 7 days post patch removal.
时间窗: Safety assessment of investigational products for irritation potential using draize scale.
次要结局
- Not Applicable(Not Applicable)