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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Jonathan Perkins, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01074437
First received: February 22, 2010
Last updated: December 11, 2013
Last verified: December 2013

February 22, 2010
December 11, 2013
February 2010
February 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Lesion Regression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measure of change in lesion area or volume
Same as current
Complete list of historical versions of study NCT01074437 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)
A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hemangioma
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
February 2013
February 2012   (final data collection date for primary outcome measure)

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
Both
up to 9 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01074437
12901
Yes
Jonathan Perkins, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: Jonathan A Perkins, DO Seattle Children's Hospital
Seattle Children's Hospital
December 2013

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