NCT00885937已完成1 期
Single-blind, Randomized, Controlled, Single Center Trial to Evaluate the Skin Irritation Potential of a New Topical Formulation by Means of an Occlusive Patch Test in Healthy Subjects.
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
- Bayer
- 入组人数
- 33
- 主要终点
- Irritation rate
研究概览
简要总结
The study is focused to prove a favorable safety profile of the new formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Age of at least 18 years
- •Skin type I, II, or III according to Fitzpatrick
- •Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
排除标准
- •Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
- •Known skin allergies.
- •Dermatologic diseases that might interfere with the evaluation of test site reaction.
- •Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
- •Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
- •Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
- •Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Dexpanthenol (Sinecort, BAY81-2996) (Drug)
Arm 2
Active Comparator
干预措施: Positive control, Na-laurylsulfat-solution (Drug)
Arm 3
Placebo Comparator
干预措施: Untreated skin under application chamber (Device)
结局指标
主要结局
Irritation rate
时间窗: After 21 applications
次要结局
- Irritation potential(After 21 applications)
研究者
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