NCT01787448已完成1 期
Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Dermal sensitization potential
研究概览
简要总结
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder
排除标准
- •Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study
研究组 & 干预措施
Ibuprofen 5% topical gel
Experimental
干预措施: Topical gel vehicle (Drug)
Topical gel vehicle
Experimental
干预措施: Topical gel vehicle (Drug)
Sodium lauryl sulfate 0.1%
Active Comparator
干预措施: Sodium lauryl sulfate 0.1% (Drug)
Sodium chloride solution 0.9% (saline)
Sham Comparator
干预措施: Sodium chloride solution 0.9% (saline) (Drug)
结局指标
主要结局
Dermal sensitization potential
时间窗: 24-72 hours after last patch removal
次要结局
- Cumulative Irritancy(48-72 hours after each patch application)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(During study through 28 days after last product application)
研究者
研究点 (1)
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