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

Phase 3
6 Months
Open (Enrolling)

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Hemangioma size

Outcome Description:

It will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30 and Day 90

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Michèle Bigorre, PH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UH Montpellier


France: The Commission nationale de l’informatique et des libertés

Study ID:




Start Date:

November 2012

Completion Date:

February 2015

Related Keywords:

  • Hemangioma
  • Hemangioma
  • Beta-blocker
  • Acebutolol
  • Propranolol
  • Randomized controlled trial
  • Infants
  • Hemangioma
  • Hemangioma, Capillary