Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

The Hospital for Sick Children20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hemangiomas

Interventions

prednisoloneDRUG

methylprednisoloneDRUG

Eligibility

Sex: ALLMin age: 1 MonthMax age: 4 Months

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Percent improvement in the appearance of hemangioma

Secondary Outcomes

Frequency of side-effects experienced by the patients

Changes in the angiogenesis markers

Data from ClinicalTrials.gov

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