COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01743885
Recruitment Status : Terminated
First Posted : December 6, 2012
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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 or disease Intervention/treatment Phase
Hemangioma Drug: Acebutolol Drug: Propanolol Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
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
Study Start Date : November 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Tolerance of treatment [ Time Frame: 3 months ]
    All adverse events are collected at each visited

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01743885

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Michèle Bigorre, PH UH Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier Identifier: NCT01743885    
Other Study ID Numbers: 8638
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by University Hospital, Montpellier:
Randomized controlled trial
Additional relevant MeSH terms:
Layout table for 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