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

NCT07104526 | Completed

• 1 other identifier: 2023R064-E01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Hemangioma (IH)

Outcome Measures

Primary Outcomes (1)

• Clinical Therapeutic Effect

  Categorized as Complete Regression (\>95% volume reduction), Marked Effectiveness (≥75% to 95% volume reduction), Effective (30% to \<75% reduction), or Ineffective (\<30% reduction). The primary measure is the rate of participants achieving Complete Regression or Marked Effectiveness.

  6 Months

Secondary Outcomes (5)

• Early Tumor Surface Atrophy

  24 hours after the first treatment

• Change in Hemangioma Color Score

  Baseline, 6 Months

• Change in Tumor Volume

  Baseline, 6 Months

• Vancouver Scar Scale (VSS) Score

  6 Months

• Incidence of Adverse Events

  Through study completion (6 months)

Study Arms (2)

Experimental: Combination Therapy Group

EXPERIMENTAL

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.

Drug: Propranolol + Bleomycin

Active Comparator: Propranolol Monotherapy Group

ACTIVE COMPARATOR

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.

Drug: Propranolol

Interventions

Propranolol + Bleomycin DRUG

Oral propranolol at 1 mg/kg/day for 6 months plus intralesional bleomycin (1 mg/mL solution) injected once monthly. The bleomycin dose was 0.2-0.5 mg per injection site, not exceeding a total of 1 mg/kg per session or a cumulative dose of 10 mg.

Experimental: Combination Therapy Group

Propranolol DRUG

Oral propranolol hydrochloride solution administered at a dose of 1 mg/kg/day for 6 months.

Active Comparator: Propranolol Monotherapy Group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: lead

Study Sites (1)

Wuhan Children's Hospital

Wuhan, Hubei, 430015, China

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Propranolol; Bleomycin

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)