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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week
UH Lyon
Lyon, France
UH Marseill
Marseille, France
Chirurgy Plastic Department
Montpellier, France
UH NCaremeau
Nîmes, France
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
Time frame: 3 months
Tolerance of treatment
All adverse events are collected at each visited
Time frame: 3 months
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma
Time frame: 3 months
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