Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

Phase 3

Completed

• Conditions: Hemangiomas

• Registration Number: NCT00312520
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-04-06
• Study First Posted: 2006-04-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent improvement in the appearance of hemangioma

Secondary Outcome Measures

Name	Time	Method
Frequency of side-effects experienced by the patients
Changes in the angiogenesis markers

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada