Propranolol in Capillary Hemangiomas

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.

The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.

The secondary objectives are:

• the kinetic of the hemangioma evolution in infants treated by propranolol

• Observance

• Safety

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• Infant aged less than 4 months

• Infant with one or more hemangiomas sized more than 1 cm diameter

• Infant not threatening for vital or functional structure and for which no treatment would be proposed

• Informed consent

• Patient with social insurance.

Exclusion Criteria:

• Alarming hemangioma (s) (complicated forms or localization at risk)

• Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension)

• Asthma

• Bronchopulmonary dysplasia

• Bronchiolitis

• Raynaud syndrome

• Phéochromocytoma

• Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment