NCT02309294已完成不适用
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Subjects That Showed no Significant Irritation
研究概览
简要总结
The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are a male or female, 18 years of age or older, in general good health;
- •Have normal skin;
- •Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
- •Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
- •Complete a medical screening procedure; and
- •Read, understand, and sign an informed consent.
排除标准
- •Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
- •Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
- •Have psoriasis and/or active atopic dermatitis/eczema; and/or
- •Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
结局指标
主要结局
Number of Subjects That Showed no Significant Irritation
时间窗: 14 days
Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).
次要结局
未报告次要终点
研究者
研究点 (2)
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