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Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

NCT01056341 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2015-12-10

Study results available
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Summary

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Conditions

  • Infantile Hemangioma

Interventions

DRUG

Propranolol

Propranolol (1 or 3 mg/kg/day for 3 or 6 months)

DRUG

Placebo

Treatment with placebo for 6 months

Sponsors & Collaborators

  • Pierre Fabre Dermatology

    lead INDUSTRY

Principal Investigators

  • Christine Labreze, MD · Hopital de Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Days
Max Age
150 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-05-31
Completion
2013-11-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Romania
  • Russia
  • Spain

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 NCT01056341 on ClinicalTrials.gov