Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

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.

Main Inclusion Criteria:

• only one proliferating Infantile Hemangioma present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter diameter ≥ 1cm and ≤ 5 cm.

Main Exclusion Criteria:

• more than one Infantile Hemangioma with largest diameter ≥ 1cm
• medically unstable health status that may interfere with his/her ability to complete the study
• Infantile Hemangioma requires, according to Investigator's judgment, a systemic treatment
• the patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH