drugset / Trial / NCT07104526

Low-Dose Propranolol and Bleomycin for Infantile Hemangioma (IH)

NCT07104526

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

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 0.2 mg Other
Subject Bleomycin Unknown 0.5 mg Other
Comparator Propranolol Small molecule 1 mg/kg Oral

Indications