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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
1, 2, and 6 months after treatment initiation
No
Jonathan A Perkins, DO
Principal Investigator
Seattle Children's Hospital
United States: Institutional Review Board
12901
NCT01074437
February 2010
February 2012
Name | Location |
---|---|
Seattle Children's Hospital | Seattle, Washington 98105 |