NCT07104526Completed
Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH)
Evaluation of the Efficacy and Safety of Low-Dose Propranolol Combined With Intralesional Bleomycin for Infantile Hemangioma: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 29 Jul 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine Hospital
- NCT number
- NCT07104526
What you commit to
- Study type: Interventional
- Participants enrolled: 260
- From 1 Jan 2024 to the primary completion date, 1 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to propranolol or bleomycin.
- Presence of other severe systemic diseases.
- PHACE syndrome or major congenital anomalies that could interfere with treatment or assessment.
Other
- Congenital or mixed hemangiomas distinct from IH.
- Significant cardiopulmonary, hepatic, or renal dysfunction.
Who the study is looking for
- 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.
Age in the registry: - to 12 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Children's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.