TerminatedPhase 2

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

Stopped: Insufficient enrollment

United States9 participantsStarted 2010-02

Plain-language summary

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.

Who can participate

Age range9 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Compare Changes in IH Size and Vascularity for the Two Treatment Groups

Timeframe: 1, 2, and 6 months after treatment initiation

Lesion Regression

Timeframe: 12 months

Trial details

NCT IDNCT01074437

SponsorSeattle Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2013-07-22