Propranolol in Capillary Hemangiomas (NCT00744185) | Clinical Trial Compass
TerminatedPhase 2/3
Propranolol in Capillary Hemangiomas
Stopped: Study halted prematurely due to some difficulties in recruitment of patients
France14 participantsStarted 2008-10
Plain-language 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
Who can participate
Age range
4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of hemangioma thickness variation measured by ultrasonography from the basal state between the two groups after 1 month-treatment.