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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00312520
Other study ID # 0020020166
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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