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

NCT01743885 | Terminated Phase 3 DMC

• 1 other identifier: 8638
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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.

Conditions

Hemangioma

Keywords

Hemangioma; Beta-blocker; Acebutolol; Propranolol; Randomized controlled trial; Infants

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (2)

• Tolerance of treatment

  3 months

• Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma

  3 months

Study Arms (2)

propanolol

ACTIVE COMPARATOR

Propanolol (Syprol:oral solution)

Drug: Propanolol

Acebutolol

ACTIVE COMPARATOR

Acebutolol (Sectral:oral solution)

Drug: Acebutolol

Interventions

Acebutolol DRUG

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

Also known as: Sectral

Acebutolol

Propanolol DRUG

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

Also known as: Syprol

propanolol

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (4)

UH Lyon

Lyon, 69130, France

Location

UH Marseill

Marseille, 13385, France

Location

Chirurgy Plastic Department

Montpellier, 34295, France

Location

UH NCaremeau

Nîmes, 30000, France

Location

MeSH Terms

Conditions

Hemangioma

Interventions

Acebutolol; Propranolol

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Michèle Bigorre, PH

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

FR (4)