NCT01743885

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	Acebutolol	10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
DRUG	Propanolol	3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-12-06
• Last updated: 2016-06-01

Locations

4 sites across 1 country: France