Propranolol in Capillary Hemangiomas

Hemangioma, Capillary Clinical Trial

— HEMANGIOMA  

Official title:

Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00744185
• Other study ID #: CHUBX 2007/27
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 28, 2008
• Last updated: July 18, 2012
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Description:

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 propranolol.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• propranolol treatment
30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
• placebo treatment
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

Locations

Country	Name	City	State
France	Dermatologie Pédiatrique	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Kilian K. Hypertension in neonates causes and treatments. J Perinat Neonatal Nurs. 2003 Jan-Mar;17(1):65-74; quiz 75-6. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.		30 days treatment	No
Secondary	Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.		30 days-treatment	Yes
Secondary	Observance		30 days-treatment	Yes