A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

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