Clinical Trial: Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Tr
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 Summary: 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.
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Percent improvement in the appearance of hemangioma
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Frequency of side-effects experienced by the patients
- Changes in the angiogenesis markers
Original Secondary Outcome: Same as current
Information By: The Hospital for Sick Children
Dates:
Date Received: April 6, 2006
Date Started: July 2002
Date Completion: June 2005
Last Updated: August 1, 2013
Last Verified: August 2013
