Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

This study has been completed.
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00312520
First received: April 6, 2006
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Hemangiomas
Drug: prednisolone
Drug: methylprednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

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

Estimated Enrollment: 20
Study Start Date: July 2002
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   1 Month to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312520

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Society for Pediatric Dermatology
Investigators
Principal Investigator: Elena Pope, MD, Msc The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Elena Pope, Head, Section of Dermatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00312520     History of Changes
Other Study ID Numbers: 0020020166
Study First Received: April 6, 2006
Last Updated: August 1, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014