Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.