Clinical trial NCT01743885: Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
Official title: Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemangioma
Keywords: Hemangioma
Beta-blocker
Acebutolol
Propranolol
Randomized controlled trial
Infants
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 55
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hemangioma size
timeFrame: 3 months
Secondary outcomes:
measure: Tolerance of treatment
timeFrame: 3 months
measure: Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma
timeFrame: 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: UH Lyon
city: Marseille
country: France
facility: UH Marseill
city: Montpellier
country: France
facility: Chirurgy Plastic Department
city: Nîmes
country: France
facility: UH NCaremeau
Study officials:
affiliation: UH Montpellier
name: Michèle Bigorre, PH
role: PRINCIPAL_INVESTIGATOR
References: