Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 4 Months (Child)
- Sex
- 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)
- •Bronchopulmonary dysplasia
- •Bronchiolitis
- •Raynaud syndrome
- •Phéochromocytoma
- •Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment
Arms & Interventions
2
30-days placebo treatment
Intervention: placebo treatment (Drug)
1
30-days propranolol treatment
Intervention: propranolol treatment (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Proportion of hemangioma size variation measured clinically and with photography from the basal state between the two groups after 1 month-treatment.(30 days-treatment)
- Observance(30 days-treatment)