NCT00488241已完成4 期
A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
Bayer1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hand eczema severity index (HECSI)at the end of study
研究概览
简要总结
To show efficacy of Zarzenda in the treatment of hand eczema
详细描述
The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate hand eczema for at least 3 months
- •At least 4 weeks have passed since use of systemic treatment for eczema
- •At least 4 weeks have passed since any vaccination
- •At least 1 week has passed since last topic treatment on hands with corticosteroids
- •Agree to use adequate contraceptive method if of childbearing potential
- •Willingness to avoid excessive exposure to sunlight and avoid skin irritants
排除标准
- •Pregnancy, breast feeding
- •Severe excoriations on the hands
- •Need for systemic treatment for atopic dermatitis
- •Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
- •Known immune deficiency
- •Concomitant infection on hands
研究组 & 干预措施
1
Active Comparator
Topically applied daily for 2 weeks
干预措施: Zarzenda (Device)
结局指标
主要结局
Hand eczema severity index (HECSI)at the end of study
时间窗: End of study compared to baseline
次要结局
- Investigator's Global Assessment(End of study compared to baseline)
- Clinical signs of hand eczema(End of study compared to baseline)
- Patients assessment of itch(End of study compared to baseline)
- Hand surface area(End of study compared to baseline)
研究者
研究点 (1)
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