Propranolol in Capillary Hemangiomas - Full Text View

Sponsor:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00744185

Purpose

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

Condition	Intervention	Phase
Hemangioma, Capillary	Drug: propranolol treatment Drug: placebo treatment	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Ultrasound

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment. [ Time Frame: 30 days-treatment ] [ Designated as safety issue: Yes ]
Observance [ Time Frame: 30 days-treatment ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	October 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 2 30-days placebo treatment	Drug: placebo treatment 30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
Experimental: 1 30-days propranolol treatment	Drug: propranolol treatment 30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days

Detailed 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.

Eligibility

Ages Eligible for Study:	up to 4 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744185

Locations

France
Dermatologie Pédiatrique
Bordeaux, France, 33 076

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Study Chair:

Nicholas Moore, Professor

University Hospital Bordeaux, France

More Information

Publications:

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. No abstract available.

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.

Responsible Party:	Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00744185 History of Changes
Other Study ID Numbers:	CHUBX 2007/27
Study First Received:	August 28, 2008
Last Updated:	April 1, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

infantile capillary hemangiomas
propranolol
ultrasonography

Additional relevant MeSH terms:

Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012