Propranolol in Capillary Hemangiomas (HEMANGIOMA)
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|ClinicalTrials.gov Identifier: NCT00744185|
Recruitment Status : Terminated (Study halted prematurely due to some difficulties in recruitment of patients)
First Posted : August 29, 2008
Last Update Posted : July 19, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Hemangioma, Capillary||Drug: propranolol treatment Drug: placebo treatment||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: 2
30-days placebo treatment
Drug: placebo treatment
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
30-days propranolol treatment
Drug: propranolol treatment
30 days-propranolol treatment : 3 mg/kg 15 days + 4 mg/kg 15 days
- 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 ]
- 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 ]
- Observance [ Time Frame: 30 days-treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744185
|Bordeaux, France, 33 076|
|Study Chair:||Nicholas Moore, Professor||University Hospital Bordeaux, France|