Hemangioma Clinical Trial
Official title:
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.
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