drugset / Trial / NCT07104526
Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH)
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bleomycin | Unknown | 0.2 mg | Other |
| Subject | Bleomycin | Unknown | 0.5 mg | Other |
| Comparator | Propranolol | Small molecule | 1 mg/kg | Oral |