Conditions: Infantile Hemangioma
Keywords: Infantile Hemangioma Propranolol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 512
Healthy volunteers: no

Brief summary:
There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Detailed description:
Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: Propranolol (1 or 3 mg/kg/day for 3 or 6 months) intervention 2: Treatment with placebo for 6 months

Protocol document: