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Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

Primary Purpose

Hemangiomas

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
prednisolone
methylprednisolone
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangiomas

Eligibility Criteria

1 Month - 4 Months (Child)All SexesDoes not accept 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: refusal to participate age > 4 months complicated nonvisible hemangiomas congenital heart disease

Sites / Locations

  • The Hospital for Sick Children

Outcomes

Primary Outcome Measures

Percent improvement in the appearance of hemangioma

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2006
Last Updated
April 17, 2018
Sponsor
The Hospital for Sick Children
Collaborators
Society for Pediatric Dermatology
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1. Study Identification

Unique Protocol Identification Number
NCT00312520
Brief Title
Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2002 (Actual)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Society for Pediatric Dermatology

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangiomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Primary Outcome Measure Information:
Title
Percent improvement in the appearance of hemangioma
Secondary Outcome Measure Information:
Title
Frequency of side-effects experienced by the patients
Title
Changes in the angiogenesis markers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Pope, MD, Msc
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

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