Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH) (NCT07104526) | Clinical Trial Compass
CompletedNot Applicable
Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH)
China260 participantsStarted 2024-01-01
Plain-language summary
This is a prospective, randomized controlled trial designed to evaluate the efficacy and safety of low-dose oral propranolol (1 mg/kg/day) combined with monthly intralesional bleomycin injections versus low-dose propranolol monotherapy for the treatment of infantile hemangioma (IH). A total of 260 infants were randomized to either the combination group or the control group. The study aims to determine if the combination therapy offers superior clinical outcomes, including faster regression, better color resolution, and reduced scarring over a 6-month treatment period.
Who can participate
Age range
12 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:
* Age ≤12 months.
* Clinically and/or imaging-diagnosed infantile hemangioma requiring treatment.
* No prior treatment for IH.
* Guardians willing to comply with the study protocol and provide informed consent.
Exclusion Criteria:
* Known hypersensitivity to propranolol or bleomycin.
* Congenital or mixed hemangiomas distinct from IH.
* Significant cardiopulmonary, hepatic, or renal dysfunction.
* Presence of other severe systemic diseases.
* PHACE syndrome or major congenital anomalies that could interfere with treatment or assessment.
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
Clinical Therapeutic Effect
Timeframe: 6 Months
Trial details
NCT IDNCT07104526
SponsorWuhan Integrated Traditional Chinese and Western Medicine Hospital