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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hemangioma

In brief

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.

Key facts

Study ID

NCT01074437

Run by

Seattle Children's Hospital

People needed

9

Starts

2010-02-01

Expected to finish

2013-02-01

Last updated by the study team

2018-10-04

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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