NCT02737618已完成不适用
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
研究概览
简要总结
to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, 18-70 years of age, in general good health
- •normal skin
- •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
- •of any skin type or race providing the skin pigmentation will allow discernment of erythema
- •agree to complete a medical history and concomitant medication form
- •read, understand and sign 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 systemic 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
- •have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
- •are females who are pregnant or breastfeeding or become pregnant
研究组 & 干预措施
Healthy subject
Experimental
Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch
干预措施: Trojan "Chameleon" Personal Lubricant (Device)
结局指标
主要结局
Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
时间窗: 14 days
Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (2)
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