NCT03441568已完成不适用
In-home Use Test of the New Modified Diprobase® Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants with adverse event (AE)
研究概览
简要总结
To investigate the safety and tolerability of the modified Diprobase formulation over 14 days in infants and children with a history of Atopic Dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse event (AE)
时间窗: Up to 14 days
Severity of adverse event
时间窗: Up to 14 days
The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe
次要结局
未报告次要终点
研究者
研究点 (2)
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