Propranolol in Capillary Hemangiomas (HEMANGIOMA)

This study has been terminated.
(Study halted prematurely due to some difficulties in recruitment of patients)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00744185
First received: August 28, 2008
Last updated: July 18, 2012
Last verified: July 2012
  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 2
Phase 3

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:


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
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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:
Responsible Party: 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: July 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014