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Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

Phase 2/Phase 3
4 Months
Not Enrolling
Hemangioma, Capillary

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Trial Information

Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.

Outcome Time Frame:

30 days treatment

Safety Issue:


Principal Investigator

Nicholas Moore, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Bordeaux, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2007/27



Start Date:

October 2008

Completion Date:

April 2010

Related Keywords:

  • Hemangioma, Capillary
  • infantile capillary hemangiomas
  • propranolol
  • ultrasonography
  • Hemangioma
  • Hemangioma, Capillary