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Propranolol in Capillary Hemangiomas (HEMANGIOMA)
This study is currently recruiting participants.
Study NCT00744185   Information provided by University Hospital, Bordeaux
First Received: August 28, 2008   Last Updated: September 28, 2009   History of Changes

August 28, 2008
September 28, 2009
October 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00744185 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Propranolol in Capillary Hemangiomas
Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

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

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Hemangioma, Capillary
  • Drug: propranolol treatment
  • Drug: placebo treatment
  • Placebo Comparator: 30-days placebo treatment
  • Experimental: 30-days propranolol treatment

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
December 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
up to 4 Months
No
Contact: Christine Labrèze, Doctor 05 56 79 59 42 christine.labreze@chu-bordeaux.fr
Contact: Eric Dumas de la Roque, Doctor 05 56 79 56 42 eric.dumas-de-la-roque@chu-bordeaux.fr
France
 
NCT00744185
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
CHUBX 2007/27
University Hospital, Bordeaux
 
Study Chair: Nicholas Moore, Professor University Hospital Bordeaux, France
University Hospital, Bordeaux
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP