Propranolol in Capillary Hemangiomas (HEMANGIOMA)
The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.
The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.
The secondary objectives are:
- the kinetic of the hemangioma evolution in infants treated by propranolol
|Hemangioma, Capillary||Drug: propranolol treatment Drug: placebo treatment||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas|
- Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days treatment ]
- Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days-treatment ]
- Observance [ Time Frame: 30 days-treatment ]
|Study Start Date:||October 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
30-days placebo treatment
Drug: placebo treatment
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
30-days propranolol treatment
Drug: propranolol treatment
30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas have a characteristic clinical course marked by early proliferation during 3 to 12 months followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause high-output cardiac failure or significant structural abnormalities. Standard treatments (corticotherapy, interferon, vincristine…) lead to a stagnation of hemangiomas in some cases, but with frequent side effects.
We observed that Propranolol, a beta-blocker usually used in neonates could lead to a decreased in volume of serious haemangiomas of the face (article published in New England Journal of Medicine).
In this study, we proposed to determine the efficiency of 1 month-early treatment of propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not justifying corticotherapy. This is a double blind randomized placebo controlled study of propranolol.
Infants will be recruited from the dermatology consultation of CHU Bordeaux. After verification of eligibility criteria and informed consent of legal surrogates, infants will be randomized to receive either propranolol or either placebo. The infants will be observed during 1 month according to the following visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744185
|Bordeaux, France, 33 076|
|Study Chair:||Nicholas Moore, Professor||University Hospital Bordeaux, France|