Research on the experiment design and data analysis of validation study for skin irritation testing

皮肤刺激试验验证研究的实验设计及数据分析研究

• 批准号: 13680376
• 负责人: SHIMURA Isao
• 金额: $ 1.73万
• 依托单位: Tokyo University of Science
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2001
• 资助国家: 日本
• 起止时间: 2001 至 2002
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-13680376/
• 关键词: skin irritancy; Japanese scoring; guestionair surney; photographic evaluation; statistical analysis; 本部芝草

This study was conducted through the collaboration with specialists in dermatology. The principal results obtained in this study are as follows: (1) Ratings on skin reaction observed by investigators with experience longer than 5 years in dermatological evaluation are reproducible, (2) Ratings on photographic specimen are slightly different from those on human bodies probably due to the lack of information for humidity and elasticity, (3) Hair shampoos in markets can be classified into 4 or 5 classes in view of troubles reported from users, (4) As the estimation method of ET50 based on the experiment data using three-dimensional cultured human models, a simple regression analysis method is robust when the observed time points are as few as 3 or 4. (5) The order effect is a major nuisance factor in evaluating irritancy in stinging test under the situation that two treatments are applied and compared on each of both cheeks of the same subject. Some of them were reported in academic meetings or journals such as the 15th Annual Meetings of The Japanese Society for Alternative to Animal Experiments or the 26th Annual Meetings of The Japanese Society for Contact Dermatitis

这项研究是通过与皮肤科专家合作进行的。本研究获得的主要结果如下：（1）具有5年以上皮肤病学评价经验的研究者观察到的皮肤反应评分具有重现性，（2）可能由于缺乏湿度和弹性信息，照相标本的评分与人体略有不同，（3）考虑到使用者报告的问题，市场上的洗发剂可以分为4或5类。（4）作为基于使用三维培养的人体模型的实验数据的ET 50的估计方法，当观察到的时间点少至3或4个时，简单的回归分析方法是稳健的。(5)顺序效应是评价刺激性的一个主要干扰因素，在刺痛试验的情况下，两种治疗方法被应用于同一受试者的两侧脸颊的每一个进行比较。其中一些在学术会议或期刊上报道，如第15届日本动物实验替代学会年会或第26届日本接触性皮炎学会年会