Evaluation of safety of Test products by primary irritation patch test on healthy human participants of varied skin types
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
The objective of this study is to evaluate the dermatological safety of the investigational products on
healthy human participants 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 ) adult participants in the age
group of 18 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
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female Participants in the age group of 18-65 years both age inclusive Participants with skin photo type III to V Participant is having apparently healthy skin on test area Participants representing normal oily dry and combination skin type in nearly equal ratio Participants willing to give a voluntary written informed consent.
排除标准
- •Hypersensitivity allergy antecedent to any cosmetic product raw material or hair dye Participants having any significant pathology Dermatological infection in the test area Participant is Pregnant or Lactating Participants participated in any other cosmetic or therapeutic trial or in a similar investigation Participant is having Scars excessive terminal hair or tattoo on the studied area.
结局指标
主要结局
Safety assessment of investigational products for
时间窗: 0 hours 24 hours and 7 days post patch removal
irritation potential using Draize scale after patch
时间窗: 0 hours 24 hours and 7 days post patch removal
removal
时间窗: 0 hours 24 hours and 7 days post patch removal
次要结局
未报告次要终点
研究者
Dr Karishma Kapoor
Auriga Research Private Limited