The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent improvement in the appearance of hemangioma
研究概览
简要总结
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.
详细描述
Currently there is no prospective study in hemangioma patients answering critical questions such as: which type of steroid should be used,how much should we use and for how long. This study is an investigator blinded study with two arms:one arm is receiving standard treatment with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids daily for 3 days, monthly for 3 months. The main outcome of the study is assess the efficacy of each treament modality as the percentage improvement in the hemangioma's appearance. The secondary outcomes are the safety profiles of the two drugs and the changes in the angiogenesis markers as a result of treatment intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
- •1-4 months of age
- •signed consent form
排除标准
- •refusal to participate
- •age > 4 months
- •complicated nonvisible hemangiomas
- •congenital heart disease
结局指标
主要结局
Percent improvement in the appearance of hemangioma
次要结局
- Frequency of side-effects experienced by the patients
- Changes in the angiogenesis markers
研究者
Elena Pope
Head, Section of Dermatology
The Hospital for Sick Children