Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Hemangiomas

Treatments

Drug: prednisolone

Drug: methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00312520

0020020166

Details and patient eligibility

About

The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.

Full 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.

Sex

All

Ages

1 to 4 months old

Volunteers

No Healthy Volunteers

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