Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hemangiomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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prednisolone

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
* 1-4 months of age
* signed consent form