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

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.

Infantile hemangioma (IH) is the most common benign vascular tumor in infancy. While oral propranolol is the first-line systemic therapy, its efficacy can be limited or slow for certain IHs. Intralesional bleomycin offers a targeted local therapy. This study investigates whether combining low-dose propranolol with local bleomycin injections can enhance therapeutic effects while maintaining a good safety profile. This prospective, randomized, controlled, open-label trial with blinded outcome assessment enrolled 260 infants with IH. Participants were randomly assigned to receive either oral propranolol (1 mg/kg/day) plus monthly intralesional bleomycin (Combination Group) or oral propranolol (1 mg/kg/day) alone (Control Group) for 6 months. The primary objective is to compare the clinical therapeutic effect between the two groups at 6 months. Secondary objectives include evaluating early tumor response, changes in tumor volume and color, long-term scar formation, and the incidence of adverse events. The findings aim to provide robust evidence for a potentially more effective combination treatment strategy for IH.

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.