NCT00312520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

April 6, 2006

Last Update Submit

April 17, 2018

Conditions

Hemangiomas

Outcome Measures

Primary Outcomes (1)

  • Percent improvement in the appearance of hemangioma

Secondary Outcomes (2)

  • Frequency of side-effects experienced by the patients

  • Changes in the angiogenesis markers

Interventions

prednisoloneDRUG
methylprednisoloneDRUG

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • refusal to participate
  • age \> 4 months
  • complicated nonvisible hemangiomas
  • congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hemangioma

Interventions

PrednisoloneMethylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Elena Pope, MD, Msc

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Section of Dermatology

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

July 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CA(1)