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
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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 |
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 |
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 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 2
30-days placebo treatment
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Drug: placebo treatment
30 days-placebo treatment : 3 mg/kg 15 days + 4 mg/kg 15 days |
Experimental: 1
30-days propranolol treatment
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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 ]

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Ages Eligible for Study: | up to 4 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744185
France | |
Dermatologie Pédiatrique | |
Bordeaux, France, 33 076 |
Study Chair: | Nicholas Moore, Professor | University Hospital Bordeaux, France |
Publications:
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00744185 History of Changes |
Other Study ID Numbers: |
CHUBX 2007/27 |
First Posted: | August 29, 2008 Key Record Dates |
Last Update Posted: | July 19, 2012 |
Last Verified: | July 2012 |
infantile capillary hemangiomas propranolol ultrasonography |
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 |