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
Bayer1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年9月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 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
- •Children with normal or dry skin and a history of mild to moderate AD, but without any signs or symptoms within the last month prior to enrollment
- •Skin type I - VI according to Fitzpatrick skin classification
- •Aged 6 months to 48 months
排除标准
- 未提供
研究组 & 干预措施
BAY987534
Experimental
Infants and children with quiescent atopic dermatitis
干预措施: Modified Diprobase formulation (BAY987534) (Device)
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 (1)
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