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

Recruiting at 58 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Pierre Fabre Dermatology

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christine Labreze, MD

Principal Investigator

Hopital de Bordeaux

Eligibility Criteria

Inclusion Criteria

Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

Treatment Details

Interventions

• Placebo (Drug)
• Propranolol Oral Solution (Beta Blocker)

Participant Groups

Group I: Propranolol oral solution Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pierre Fabre Dermatology

Lead Sponsor

Trials

4

Recruited

640+