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

Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01743885
• Other study ID #: 8638
• Status: Terminated
• Phase: Phase 3
• First received: November 28, 2012
• Last updated: May 31, 2016
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• Acebutolol
10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
• Propanolol
3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week

Locations

Country	Name	City	State
France	UH Lyon	Lyon
France	UH Marseill	Marseille
France	Chirurgy Plastic Department	Montpellier
France	UH NCaremeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemangioma size	It will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30 and Day 90	3 months	No
Secondary	Tolerance of treatment	All adverse events are collected at each visited	3 months	Yes
Secondary	Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma		3 months	No