Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

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: NCT01074437
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : February 24, 2010
Results First Posted : September 26, 2013
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Perkins, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE February 24, 2010
Results First Submitted Date  ICMJE July 22, 2013
Results First Posted Date  ICMJE September 26, 2013
Last Update Posted Date October 4, 2018
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • Compare Changes in IH Size and Vascularity for the Two Treatment Groups [ Time Frame: 1, 2, and 6 months after treatment initiation ]
    This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
  • Lesion Regression [ Time Frame: 12 months ]
    measure of change in lesion area or volume
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol [ Time Frame: 1, 2, and 6 months after treatment initiation ]
Change History Complete list of historical versions of study NCT01074437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone. [ Time Frame: 1, 2, and 6 months after treatment initiation ]
    This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
  • Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH. [ Time Frame: 1, 2 and 6 months after treatment initiation ]
    This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
  • Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner. [ Time Frame: 1, 2 and 6 months after treatment initiation ]
    This outcome cannot be evaluated. Trial limited by lack of patient family to have randomization, which limited the number of participants and made the project nonviable.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
  • Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone. [ Time Frame: 1, 2, and 6 months after treatment initiation ]
  • Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH. [ Time Frame: 1, 2 and 6 months after treatment initiation ]
  • Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner. [ Time Frame: 1, 2 and 6 months after treatment initiation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Official Title  ICMJE A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
Brief Summary This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.
Detailed Description

Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. Medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. Recent reports and our own experience have demonstrated that significant reduction in IH size and vascularity can also occur through the use of propranolol. Our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. Despite this experience, the standard of care for initial IH medical therapy remains corticosteroids.

This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hemangioma
Intervention  ICMJE
  • Drug: Prednisolone (Corticosteroid)
    Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.
    Other Name: Corticosteroids
  • Drug: Propranolol
    Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.
    Other Name: Propranolol hydrochloride (USP/EP) Oral Solution
  • Drug: Placebo
    Liquid placebo will be given during the two month treatment trial.
    Other Names:
    • Inactive drug
    • Inactive substance
    • Inactive medicine
Study Arms  ICMJE
  • Group A: Corticosteroid with Placebo
    Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
    Interventions:
    • Drug: Prednisolone (Corticosteroid)
    • Drug: Placebo
  • Group B: Corticosteroid with Propranolol
    Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
    Interventions:
    • Drug: Prednisolone (Corticosteroid)
    • Drug: Propranolol
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 22, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
60
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 0 to < 9months
  • Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment
  • IH patients whose parents desire medical treatment for the IH
  • Stable cardiac function

Exclusion Criteria:

  • IH patients over 9 months of age.
  • Hypersensitivity to propranolol
  • Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.
  • Atrioventricular (AV) block
  • Resting heart < 2 SD of normal*(below)
  • Resting blood pressure < 2 SD of normal**(below)
  • Wolff-Parkinson-White syndrome (WPW)
  • History of unexplained syncope
  • Bronchial asthma
  • History of impaired renal or liver function
  • Diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 9 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01074437
Other Study ID Numbers  ICMJE 12901
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Perkins, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan A Perkins, DO Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date September 2018

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