Trial | NCT00312520  Report issue

Title

Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.
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.
Study Started
Jul 31
2002
Primary Completion
Jun 30
2005
Study Completion
Jun 30
2005
Last Update
Apr 19
2018

Drug prednisolone

Drug methylprednisolone

Criteria 

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
No Results Posted