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Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

This study has been terminated.
Information provided by (Responsible Party):
University Hospital, Montpellier Identifier:
First received: November 28, 2012
Last updated: May 31, 2016
Last verified: May 2016
There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.

Condition Intervention Phase
Hemangioma Drug: Acebutolol Drug: Propanolol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

Resource links provided by NLM:

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Hemangioma size [ Time Frame: 3 months ]
    It will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30 and Day 90

Secondary Outcome Measures:
  • Tolerance of treatment [ Time Frame: 3 months ]
    All adverse events are collected at each visited

  • Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma [ Time Frame: 3 months ]

Enrollment: 55
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propanolol
Propanolol (Syprol:oral solution)
Drug: Propanolol
3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week
Other Name: Syprol
Active Comparator: Acebutolol
Acebutolol (Sectral:oral solution)
Drug: Acebutolol
10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
Other Name: Sectral


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants under 6 months
  • Presenting a hemangioma with the following characteristics:

    • subcutaneous and / or cutaneous
    • minimum diameter of 1.5cm on face, 5cm outside face and 3cm if it is ulcerated.
    • without functional impairment requiring treatment or vital corticosteroid
  • Consent of both parents (or the person having parental authority in families)
  • Which at least one parent is a beneficiary of a social security system.

Exclusion Criteria:

  • Indication of treatment with corticosteroids for an indication other than hemangioma
  • Indication of treatment with beta-blocker for another indication that the hemangioma
  • Infant presenting cons-indications for the administration of acebutolol or propranolol:

    • Asthma and chronic obstructive pulmonary disease in their severe forms.
    • Heart failure controlled by treatment.
    • Cardiogenic shock
    • Prinzmetal Angina
    • Bradycardia (<80 beats / min at rest the first month <70/minute from 1 to 6 month).
    • Raynaud's phenomenon and peripheral arterial disorders in their severe forms.
    • Pheochromocytoma untreated.
    • Low blood pressure (blood pressure <60/30 mmHg before 6 months)
    • Hypersensitivity to acebutolol or propranolol
    • History of anaphylactic reaction.
    • Treatment with amiodarone and / or calcium channel blockers.
    • Congenital heart disease outside inter auricular communication (CIA) or inter ventricular communication (CIV) insignificant
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Please refer to this study by its identifier: NCT01743885

UH Lyon
Lyon, France, 69130
UH Marseill
Marseille, France, 13385
Chirurgy Plastic Department
Montpellier, France, 34295
UH NCaremeau
Nîmes, France, 30000
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Michèle Bigorre, PH UH Montpellier
  More Information

Responsible Party: University Hospital, Montpellier Identifier: NCT01743885     History of Changes
Other Study ID Numbers: 8638
Study First Received: November 28, 2012
Last Updated: May 31, 2016

Keywords provided by University Hospital, Montpellier:
Randomized controlled trial

Additional relevant MeSH terms:
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
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
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists processed this record on August 22, 2017