Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
30 days treatment
Nicholas Moore, Professor
University Hospital Bordeaux, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)