Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
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ClinicalTrials.gov Identifier: NCT01056341 |
Recruitment Status :
Completed
First Posted : January 26, 2010
Results First Posted : June 24, 2014
Last Update Posted : December 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infantile Hemangioma | Drug: Propranolol Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 512 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind). |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | November 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Propranolol oral solution |
Drug: Propranolol
Propranolol (1 or 3 mg/kg/day for 3 or 6 months) |
Placebo Comparator: Placebo |
Drug: Placebo
Treatment with placebo for 6 months |
- Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. [ Time Frame: 6 months ]
- Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. [ Time Frame: 6 months ]
- Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48. [ Time Frame: 6 months ]Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits

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Ages Eligible for Study: | 35 Days to 150 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
- The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
- The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
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One or more of the following types of IH are present:
- Life-threatening IH
- Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
- Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
- The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
- LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056341

Study Chair: | Christine Labreze, MD | Hopital de Bordeaux |
Other Publications:
Responsible Party: | Pierre Fabre Dermatology |
ClinicalTrials.gov Identifier: | NCT01056341 |
Other Study ID Numbers: |
V00400 SB 201 Study |
First Posted: | January 26, 2010 Key Record Dates |
Results First Posted: | June 24, 2014 |
Last Update Posted: | December 10, 2015 |
Last Verified: | November 2015 |
Infantile Hemangioma Propranolol |
Hemangioma Hemangioma, Capillary Port-Wine Stain Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Skin Abnormalities Congenital Abnormalities Skin Diseases Propranolol |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents |