NCT01074437

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

A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 9 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	Prednisolone (Corticosteroid)	Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.
DRUG	Propranolol	Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.
DRUG	Placebo	Liquid placebo will be given during the two month treatment trial.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2013-02-01
• First posted: 2010-02-24
• Last updated: 2018-10-04
• Results posted: 2013-09-26

Locations

1 site across 1 country: United States