Propranolol in Capillary Hemangiomas (HEMANGIOMA)

• ClinicalTrials.gov Identifier: NCT00744185
• Recruitment Status: Terminated
• First Posted: August 29, 2008
• Last Update Posted: July 19, 2012
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Hemangioma, Capillary	Drug: propranolol treatment; Drug: placebo treatment	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
• Study Start Date: October 2008
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. Observance [ Time Frame: 30 days-treatment ]

Eligibility Criteria

• Ages Eligible for Study: up to 4 Months (Child)
• Sexes Eligible for Study: All
• 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

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. 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.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT00744185 History of Changes
• Other Study ID Numbers: CHUBX 2007/27
• First Posted: August 29, 2008
• Last Update Posted: July 19, 2012
• Last Verified: July 2012

Keywords provided by University Hospital, Bordeaux:

infantile capillary hemangiomas; propranolol; ultrasonography

Additional relevant MeSH terms:

Hemangioma; Hemangioma, Capillary; Port-Wine Stain; Propranolol; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Abnormalities; Congenital Abnormalities; Skin Diseases; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents