NCT01935869已完成1 期
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100
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
- LEO Pharma
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Number of subjects with positive sensitisation reaction at each test site in the challenge phase
研究概览
简要总结
The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
- •Healthy male or female subjects, 18 to 65 years of age inclusive at screening.
排除标准
- •Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
- •Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis)
- •Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
研究组 & 干预措施
LEO 90100
Experimental
干预措施: LEO 90100 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
Petrolatum ointment
Other
干预措施: Petrolatum ointment (Drug)
结局指标
主要结局
Number of subjects with positive sensitisation reaction at each test site in the challenge phase
时间窗: 6 weeks
Mean Cumulative Irritation index and maximal dermal response during induction phase
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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