Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
- Conditions
- Hemangiomas
- Registration Number
- NCT00312520
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
- 1-4 months of age
- signed consent form
- refusal to participate
- age > 4 months
- complicated nonvisible hemangiomas
- congenital heart disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent improvement in the appearance of hemangioma
- Secondary Outcome Measures
Name Time Method Frequency of side-effects experienced by the patients Changes in the angiogenesis markers
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada