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A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

Phase 2
9 Months
Open (Enrolling)

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Trial Information

A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

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.

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

Type of Study:


Study Design:

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

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

Outcome Time Frame:

1, 2, and 6 months after treatment initiation

Safety Issue:


Principal Investigator

Jonathan A Perkins, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Children's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

February 2012

Related Keywords:

  • Hemangioma
  • Hemangioma
  • Hemangioma, Capillary



Seattle Children's Hospital Seattle, Washington  98105