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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01074437
First received: February 22, 2010
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemangioma
 Drug: Prednisolone (Corticosteroid)
Drug: Propanolol
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Steroids
U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: Placebo
Liquid placebo will be given during the two month treatment trial.
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.
 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: Propanolol
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

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.

  Eligibility

Ages Eligible for Study:   up to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • AV block
  • Resting heart < 2SD of normal*(below)
  • Resting blood pressure < 2SD of normal**(below)
  • WPW (Wolff-Parkinson-White syndrome)
  • History of unexplained syncope
  • Bronchial asthma
  • History of impaired renal or liver function
  • Diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074437

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Jonathan A Perkins, DO Seattle Children's Hospital
  More Information

Additional Information:
Seattle Children's Vascular Anomalies Program  This link exits the ClinicalTrials.gov site
Research Flyer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01074437     History of Changes
Other Study ID Numbers: 12901
Study First Received: February 22, 2010
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Propranolol
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Arrhythmia Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 16, 2013