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

Wuhan Integrated Traditional Chinese and Western Medicine Hospital

Status: Completed

Conditions: Infantile Hemangioma (IH)

Treatments: Drug: Propranolol; Drug: Propranolol + Bleomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT07104526

2023R064-E01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 260 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Experimental: Combination Therapy Group

Experimental 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.

Treatment:

Drug: Propranolol + Bleomycin

Active Comparator: Propranolol Monotherapy Group

Active Comparator 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.

Treatment:

Drug: Propranolol