Efficacy and safety of acebutolol versus propranolol in the proliferative phase of infantile hemangiomas

Conditions: Infant 0 to 6 months Non-serious hemangioma
MedDRA version: 14.1Level: LLTClassification code 10019400Term: Hemangioma of skin and subcutaneous tissueSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-004145-41-FR

Lead Sponsor: H Montpellier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Infant 0 to 6 months
hemangioma with the following characteristics: subcutaneous and / or skin, minimum diameter of 1.5 cm for the face and 5 cm outside the face or 3 cm if ulcerated, without functional impairment or requiring treatment with steroid
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-indication for a treatment with corticosteroids for an indication other than the hemangioma
-indication for a Beta-blocker therapy for an indication other than the hemangioma
-any contre indication to the administration of propranolol or acebutolol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to evaluate the clinical efficacy and safety of a three months treatment by acebutolol (10mg/kg/j) compared to propranolol (3mg/kg/j) on the proliferative phase of non-severe infantile hemangioma no requiring corticosteroids;Secondary Objective: -Compare the adverse effects of treatments <br>-Compare the effectiveness of treatments on the proliferation of hemangioma from Doppler measurements <br>- Study the evolution of the clinical efficacy of acebutolol and propranolol ;Primary end point(s): Reducing the volume of the hemangioma in 90 days. The volume of the hemangioma will be evaluated using a visual analog scale on standardized photographs.;Timepoint(s) of evaluation of this end point: Each patient wil attend a total of 5 scheduled visits (day 1, day 7, day 30, day 60, day 90). Safety will be assess at each visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluation of tolerance, measuring the thickness of the hemangioma by Doppler in a standardized manner (reference constant), measurement of vascularization (number of vaisseaux/cm2), Index of resistance and echogenicity.;Timepoint(s) of evaluation of this end point: Each patient wil attend a total of 5 scheduled visits (day 1, day 7, day 30, day 60, day 90). Safety will be assess at each visit. <br>