Infant 0 to 6 months Non-serious hemangioma MedDRA version: 14.1 Level: LLT Classification code 10019400 Term: Hemangioma of skin and subcutaneous tissue System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: acebutolol
Pharmaceutical Form: Oral solution
Trade Name: syprol
Pharmaceutical Form: Oral solution
Sponsors
UH Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -Compare the effectiveness of treatments on the proliferation of hemangioma from Doppler measurements - 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Contacts
Public ContactDRC
Research and Innovation Department
Outcome results
None listed