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Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

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.
 
ClinicalTrials.gov Identifier: NCT00312520
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE April 6, 2006
First Posted Date  ICMJE April 10, 2006
Last Update Posted Date April 19, 2018
Actual Study Start Date  ICMJE July 2002
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
Percent improvement in the appearance of hemangioma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
  • Frequency of side-effects experienced by the patients
  • Changes in the angiogenesis markers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Hemangiomas
Intervention  ICMJE
  • Drug: prednisolone
  • Drug: methylprednisolone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April 6, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312520
Other Study ID Numbers  ICMJE 0020020166
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elena Pope, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Society for Pediatric Dermatology
Investigators  ICMJE
Principal Investigator: Elena Pope, MD, Msc The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP