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

Primary Purpose

Hemangioma

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Acebutolol
Propanolol
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma focused on measuring Hemangioma, Beta-blocker, Acebutolol, Propranolol, Randomized controlled trial, Infants

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Lyon
  • UH Marseill
  • Chirurgy Plastic Department
  • UH NCaremeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propanolol

Acebutolol

Arm Description

Propanolol (Syprol:oral solution)

Acebutolol (Sectral:oral solution)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance of treatment
All adverse events are collected at each visited
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma

Full Information

First Posted
November 28, 2012
Last Updated
May 31, 2016
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01743885
Brief Title
Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
Official Title
Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
Hemangioma, Beta-blocker, Acebutolol, Propranolol, Randomized controlled trial, Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propanolol
Arm Type
Active Comparator
Arm Description
Propanolol (Syprol:oral solution)
Arm Title
Acebutolol
Arm Type
Active Comparator
Arm Description
Acebutolol (Sectral:oral solution)
Intervention Type
Drug
Intervention Name(s)
Acebutolol
Other Intervention Name(s)
Sectral
Intervention Description
10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
Intervention Type
Drug
Intervention Name(s)
Propanolol
Other Intervention Name(s)
Syprol
Intervention Description
3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week
Primary Outcome Measure Information:
Title
Hemangioma size
Description
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
Secondary Outcome Measure Information:
Title
Tolerance of treatment
Description
All adverse events are collected at each visited
Time Frame
3 months
Title
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle Bigorre, PH
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Lyon
City
Lyon
ZIP/Postal Code
69130
Country
France
Facility Name
UH Marseill
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Chirurgy Plastic Department
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
UH NCaremeau
City
Nîmes
ZIP/Postal Code
30000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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