Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

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.

Inclusion Criteria:

- Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body
except on the diaper area with largest diameter of at least 1.5 cm

Exclusion Criteria:

- The patient presents with one or more of the following medical conditions: Congenital
hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40
mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or
third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm);
severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus
syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome
with central nervous system involvement

- The patient has previously been treated for IH, including any surgical and/or medical
procedures (e.g. laser therapy)

- The patient is known to have a hypersensitivity to propranolol and/or any other
beta-blockers

- One or more of the following types of IH are present:

- Life-threatening IH

- Function-threatening IH (e.g. those causing impairment of vision, respiratory
compromise caused by airway lesions, etc.)

- Ulcerated IH (whatever the localisation) with pain and lack of response to
simple wound care measures

- The patient was born prematurely and has not yet reached his/her term equivalent age
(e.g. an infant born 2 months prematurely cannot be included before the age of 2
months)

- LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or
hereditary arrhythmia disorder