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

Seattle Children's Healthcare System

Status and phase: Terminated; Phase 2

Conditions: Hemangioma

Treatments: Drug: Prednisolone (Corticosteroid); Drug: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01074437

12901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: Under 9 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups

Group A: Corticosteroid with Placebo

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: Prednisolone (Corticosteroid)

Group B: Corticosteroid with Propranolol

Other group

Description:

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.

Treatment:

Drug: Propranolol

Drug: Prednisolone (Corticosteroid)