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
1 Month
4 Months
Both
Hemangiomas
Trial Information
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
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.
Inclusion Criteria:
- problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual
obstruction, large/dysfiguring hemangiomas)
- 1-4 months of age
- signed consent form
Exclusion Criteria:
- refusal to participate
- age > 4 months
- complicated nonvisible hemangiomas
- congenital heart disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Outcome Measure:
Percent improvement in the appearance of hemangioma
Principal Investigator
Elena Pope, MD, Msc
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Hospital for Sick Children
Authority:
Canada: Health Canada
Study ID:
2002/166
NCT ID:
NCT00312520
Start Date:
July 2002
Completion Date:
June 2005
Related Keywords:
- Hemangiomas
- Hemangioma
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