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Brief Title: Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
Official Title: A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
Study ID: NCT01512173
Brief Summary: There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile. Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use. The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.
Detailed Description:
Minimum Age: 35 Days
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique, Bordeaux, , France
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique, Lille, , France
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes, Lyon Bron, , France
CHU Timone - Service de dermatologie, Marseille, , France
Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique, Nantes, , France
CHU Necker enfants malades - Service de dermatologie, Paris, , France
CHU Saint-Etienne Hôpital Nord - Service de dermatologie, Saint-Etienne, , France
CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique, Toulouse, , France
Hôpital de Clocheville - Centre de Pédiatrie Gatien, Tours, , France
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed, Gdańsk, , Poland
Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej, Lodz, , Poland
Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii, Warszawa, , Poland
Hospital Sant Pau de Barcelona, Barcelona, , Spain
Hospital Universitario Infantil Niño Jesús, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain