Propranolol in Capillary Hemangiomas
Information source: University Hospital, Bordeaux
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemangioma, Capillary
Intervention: propranolol treatment (Drug); placebo treatment (Drug)
Phase: Phase 2/Phase 3
Sponsored by: University Hospital, Bordeaux
Official(s) and/or principal investigator(s):
Nicholas Moore, Professor, Study Chair, Affiliation: University Hospital Bordeaux, France
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
The secondary objectives are:
- the kinetic of the hemangioma evolution in infants treated by propranolol
Official title: Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.
Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond
to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas
have a characteristic clinical course marked by early proliferation during 3 to 12 months
followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as
esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause
high-output cardiac failure or significant structural abnormalities. Standard treatments
(corticotherapy, interferon, vincristine…) lead to a stagnation of hemangiomas in some
cases, but with frequent side effects.
We observed that Propranolol, a beta-blocker usually used in neonates could lead to a
decreased in volume of serious haemangiomas of the face (article published in New England
Journal of Medicine).
In this study, we proposed to determine the efficiency of 1 month-early treatment of
propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not
justifying corticotherapy. This is a double blind randomized placebo controlled study of
Infants will be recruited from the dermatology consultation of CHU Bordeaux. After
verification of eligibility criteria and informed consent of legal surrogates, infants will
be randomized to receive either propranolol or either placebo. The infants will be observed
during 1 month according to the following visits.
Minimum age: N/A.
Maximum age: 4 Months.
- 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.
- Alarming hemangioma (s) (complicated forms or localization at risk)
- Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias,
- Bronchopulmonary dysplasia
- Raynaud syndrome
- Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection,
respiratory distress) requiring standard treatment
Locations and Contacts
Dermatologie Pédiatrique, Bordeaux 33 076, France
Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819.
Tortoriello TA, Snyder CS, Smith EO, Fenrich AL Jr, Friedman RA, Kertesz NJ. Frequency of recurrence among infants with supraventricular tachycardia and comparison of recurrence rates among those with and without preexcitation and among those with and without response to digoxin and/or propranolol therapy. Am J Cardiol. 2003 Nov 1;92(9):1045-9.
Villain E, Denjoy I, Lupoglazoff JM, Guicheney P, Hainque B, Lucet V, Bonnet D. Low incidence of cardiac events with beta-blocking therapy in children with long QT syndrome. Eur Heart J. 2004 Aug;25(16):1405-11.
Kilian K. Hypertension in neonates causes and treatments. J Perinat Neonatal Nurs. 2003 Jan-Mar;17(1):65-74; quiz 75-6. Review.
Fritz KI, Bhat AM. Effect of beta-blockade on symptomatic dexamethasone-induced hypertrophic obstructive cardiomyopathy in premature infants: three case reports and literature review. J Perinatol. 1998 Jan-Feb;18(1):38-44. Review.
Starting date: October 2008
Last updated: July 18, 2012