NCT02737631已完成不适用
Human Repeat Insult Patch Test to Evaluate Personal Lubricants
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2016年2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
- 222
- 试验地点
- 2
- 主要终点
- Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
研究概览
简要总结
The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.
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
盲法说明
All participants receive the same interventions
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good health as determined from screener
- •signed and dated informed consent
- •signed and dated HIPAA Form
排除标准
- •subjects on test at any other research laboratory or clinic
- •known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
- •pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
- •pre-existing other medical conditions (e.g. adult asthma, diabetes).
- •treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
- •chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs [except for therapeutic maintenance dosage of aspirin], antibiotics, steroid inhalers, etc.)
- •known pregnant or nursing women
结局指标
主要结局
Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge
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
研究点 (2)
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