Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

Hemangiomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312520
• Other study ID #: 0020020166
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2006
• Last updated: April 17, 2018
• Start date: July 2002
• Est. completion date: June 2005

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangiomas

Intervention

Drug:
• prednisolone

• methylprednisolone

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Society for Pediatric Dermatology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent improvement in the appearance of hemangioma
Secondary	Frequency of side-effects experienced by the patients
Secondary	Changes in the angiogenesis markers

External Links

•   please see published results using the link