A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- skin sensitization reaction
研究概览
简要总结
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
详细描述
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •healthy volunteers
- •male or female subjects
- •aged 18 - 65 years
- •ability to understand and fulfill the study requirements
排除标准
- •affected skin in designated test area
- •pregnancy or lactation
- •not willing to comply with study requirements
研究组 & 干预措施
Verum
Topical application of verum (azelaic acid pre foam formulation) on the skin
干预措施: azelaic acid pre foam formulation (Drug)
Vehicle
Topical application of vehicle formulation (same as verum but without active drug substance) on the skin
干预措施: Vehicle pre foam formulation (Drug)
Negative control
Topical application of distilled water (negative control) on the skin
干预措施: Water (Drug)
结局指标
主要结局
skin sensitization reaction
时间窗: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
skin reactions will be assessed, using a standardized scoring scale
次要结局
未报告次要终点