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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT01743885

Collaborator

(none)

Enrollment

Locations

Arms

30.9

Duration (Months)

13.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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 Names: 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 Names: Sectral

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 Names:

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 Names:

Sectral

Outcome Measures

Primary Outcome Measures

Hemangioma size [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

Tolerance of treatment [3 months]
All adverse events are collected at each visited
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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