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Beta Blocker

Propranolol oral solution for Infantile Hemangiomas

Phase 2 & 3
Waitlist Available
Research Sponsored by Pierre Fabre Dermatology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Infantile Hemangiomas

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Propranolol oral solutionExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
FDA approved

Find a Location

Who is running the clinical trial?

Pierre Fabre DermatologyLead Sponsor
3 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Infantile Hemangiomas
82 Patients Enrolled for Infantile Hemangiomas
Christine Labreze, MDStudy ChairHopital de Bordeaux
~32 spots leftby Nov 2025
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