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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propanolol | Active Comparator | Propanolol (Syprol:oral solution) |
|
| Acebutolol | Active Comparator | Acebutolol (Sectral:oral solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acebutolol | Drug | 10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of treatment | All adverse events are collected at each visited | 3 months |
| Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma |
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Inclusion Criteria:
Infants under 6 months
Presenting a hemangioma with the following characteristics:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Michèle Bigorre, PH | UH Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Lyon | Lyon | 69130 | France | |||
| UH Marseill |
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| ID | Term |
|---|---|
| D006391 | Hemangioma |
| ID | Term |
|---|---|
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000070 | Acebutolol |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Propanolol | Drug | 3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week |
|
|
| 3 months |
| Marseille |
| 13385 |
| France |
| Chirurgy Plastic Department | Montpellier | 34295 | France |
| UH NCaremeau | Nîmes | 30000 | France |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |