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

NCT01074437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-10-04

Study results available
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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.

Conditions

  • Hemangioma

Interventions

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.

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Jonathan A Perkins, DO · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01074437 on ClinicalTrials.gov