Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangioma (IH) | Infantile Hemangioma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Propranolol | Drug | — | UNRESOLVED |
| Propranolol + Bleomycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Combination Therapy Group
- description
- Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses) for 6 months, combined with intralesional injections of bleomycin. Bleomycin injections were administered once a month for up to 6 months.
- interventionNames
- Drug: Propranolol + Bleomycin
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Propranolol Monotherapy Group
- description
- Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses). The total treatment duration was 6 months.
- interventionNames
- Drug: Propranolol
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 12 Months
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available