Hemangiomas
Conditions
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.
Interventions
DRUGprednisolone
DRUGmethylprednisolone
Sponsors
Society for Pediatric Dermatology
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
1 Months to 4 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement in the appearance of hemangioma | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of side-effects experienced by the patients | — |
| Changes in the angiogenesis markers | — |
Countries
Canada
Outcome results
None listed