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NCT Number: NCT07104526

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

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.

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Key information

Conditions

Infantile Hemangioma (IH) Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Children's Hospital

Wuhan, Hubei, 430015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Propranolol

Drug

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

Primary outcomes

  1. Clinical Therapeutic Effect

    Time frame: 6 Months

    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.

Secondary outcomes

  1. Early Tumor Surface Atrophy

    Time frame: 24 hours after the first treatment

    Assessed by comparing photographs and graded as Obvious Atrophy, Mild Atrophy, or No Obvious Change.

  2. Change in Hemangioma Color Score

    Time frame: Baseline, 6 Months

    Rated on a 4-point subjective scale (0-3) based on standardized digital photographs, where a lower score indicates color closer to normal skin. The change from baseline is assessed.

  3. Change in Tumor Volume

    Time frame: Baseline, 6 Months

    Measured in cubic centimeters (cm³) using high-frequency color Doppler ultrasound (Volume = length × width × height × 0.52). The change from baseline is assessed.

  4. Vancouver Scar Scale (VSS) Score

    Time frame: 6 Months

    Assessed at the former hemangioma site. The VSS evaluates pigmentation, vascularity, pliability, and height, with a total score from 0 (normal skin) to 13 (worst scar). Lower scores indicate better outcomes.

  5. Incidence of Adverse Events

    Time frame: Through study completion (6 months)

    Number and type of local and systemic adverse events reported by guardians or observed clinically (e.g., injection site reactions, bradycardia, hypoglycemia, sleep disturbances).

Sponsors and collaborators

Lead sponsor

Wuhan Integrated Traditional Chinese and Western Medicine Hospital

Other

Registry information

Official study title

Evaluation of the Efficacy and Safety of Low-Dose Propranolol Combined With Intralesional Bleomycin for Infantile Hemangioma: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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