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 range

9 Months

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Hemangioma trials