Propranolol (1 mg/kg/day) with Intralesional Bleomycin versus Propranolol Monotherapy for Infantile Hemangioma: A Randomized Controlled Trial

Yanyan GuoXinxian LiuSicheng HeBin Zhou^*

• Wuhan children's hospital, Wuhan, China

Objective: To evaluate the efficacy and safety of oral propranolol (1 mg/kg/day) combined with intralesional bleomycin injections versus propranolol monotherapy at the same dosage for infantile hemangioma (IH). This study investigates if a low-dose propranolol regimen can be enhanced with local therapy to improve outcomes while maintaining a favorable safety profile. Methods: This single-center, prospective, randomized controlled trial enrolled 260 infants (aged 3-11 months, mean age 5.34±2.57 months) with IH requiring systemic therapy. Participants were randomly assigned (1:1) to either the combination group (propranolol plus monthly intralesional bleomycin, n=130) or the monotherapy group (propranolol alone, n=130). The primary efficacy endpoint was the proportion of patients achieving an excellent therapeutic response (complete regression or marked effectiveness) at 6 months. Secondary outcomes included early therapeutic response, changes in hemangioma color score, tumor volume reduction, Vancouver Scar Scale (VSS) scores, and incidence of adverse events. Results: Baseline characteristics were comparable. After 6 months, a significantly higher proportion of patients in the combination group achieved the primary endpoint (77.69% vs. 50.00%; P<0.001). The combination group had higher rates of complete regression (33.07% vs. 15.38%, P=0.001) and marked effectiveness (44.61% vs. 34.61%, P=0.083). A superior early response was noted in the combination group, with a more pronounced degree of tumor atrophy within 24 hours (P<0.001). Post-treatment color scores (change from baseline, P<0.001) and tumor volume (1.63±0.70 cm³ vs. 3.27±1.06 cm³, P<0.001) were significantly better in the combination group. VSS scores were significantly lower in the combination group (3.68±0.37 vs. 5.75±0.64; P<0.001), indicating less scarring. Safety profiles were comparable. Conclusion: In infants with IH, augmenting a low-dose oral propranolol regimen (1 mg/kg/day) with monthly intralesional bleomycin is significantly more effective than low-dose propranolol monotherapy. This combination strategy accelerates tumor regression and yields superior cosmetic outcomes, all while maintaining a comparable safety profile.