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Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312520
First Posted: April 10, 2006
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Single
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 Elena Pope, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 6, 2006
First Posted: April 10, 2006
Last Update Posted: August 2, 2013
Last Verified: August 2013

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


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