NCT02297841已完成不适用
Repeated Insult Patch Test of Personal Lubricants
Church & Dwight Company, Inc.0 个研究点目标入组 209 人开始时间: 2014年11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
- 209
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application 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
- •In general good health
- •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
- •Read, understand, and sign an informed consent agreement
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.
- •Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
- •Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 24, 48, and 72 hours after patch application
次要结局
未报告次要终点
研究者
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