Skip to main content
OpenTrials
Completed

NCT Number: NCT00312520

Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemangiomas Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

1 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

methylprednisolone

Drug

Primary outcomes

  1. Percent improvement in the appearance of hemangioma

Secondary outcomes

  1. Frequency of side-effects experienced by the patients

  2. Changes in the angiogenesis markers

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Society for Pediatric Dermatology

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 10, 2006
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.