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

Hemangioma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hemangioma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Acebutolol10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week

Drug:Propanolol3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

propanololPropanolol (Syprol:oral solution)

AcebutololAcebutolol (Sectral:oral solution)

Study Status

Terminated

Start Date: November 2012

Completed Date: June 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Hemangioma size

Secondary Outcome: Tolerance of treatment

Study sponsors, principal investigator, and references

Principal Investigator: Michèle Bigorre, PH

Lead Sponsor: University Hospital, Montpellier

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01743885

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