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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01743885
First received: November 28, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743885

Contacts
Contact: Michèle Bigorre, PH m-bigorre@chu-montpellier.fr

Locations
France
UH Lyon Not yet recruiting
Lyon, France, 69130
Contact: Isabelle JAMES, MD       i.james@valdouest.fr   
Sub-Investigator: Isabelle JAMES, MD         
UH Marseill Not yet recruiting
Marseille, France, 13385
Contact: Alain FRAISSE, MD       alain.fraisse@ap-hm.fr   
Sub-Investigator: Alain FRAISSE, MD         
Chirurgy Plastic Department Recruiting
Montpellier, France, 34295
Contact: Michele Bigorre, MD       m-bigorre@chu-montpellier.fr   
Principal Investigator: Michele BIGORRE, MD         
UH NCaremeau Not yet recruiting
Nîmes, France, 30000
Contact: Myriam MARQUE, MD       myriam.marque@chu-nimes.fr   
Sub-Investigator: Myriam MARQUE, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Michèle Bigorre, PH UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01743885     History of Changes
Other Study ID Numbers: 8638
Study First Received: November 28, 2012
Last Updated: April 10, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Hemangioma
Beta-blocker
Acebutolol
Propranolol
Randomized controlled trial
Infants

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Propranolol
Acebutolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on September 16, 2014