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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early Tumor Surface Atrophy | Assessed by comparing photographs and graded as Obvious Atrophy, Mild Atrophy, or No Obvious Change. | 24 hours after the first treatment |
| Change in Hemangioma Color Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Children's Hospital | Wuhan | Hubei | 430015 | China |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D001761 | Bleomycin |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Propranolol | Drug | Oral propranolol hydrochloride solution administered at a dose of 1 mg/kg/day for 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.
| Baseline, 6 Months |
| Change in Tumor Volume | Measured in cubic centimeters (cm³) using high-frequency color Doppler ultrasound (Volume = length × width × height × 0.52). The change from baseline is assessed. | Baseline, 6 Months |
| Vancouver Scar Scale (VSS) Score | 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. | 6 Months |
| Incidence of Adverse Events | Number and type of local and systemic adverse events reported by guardians or observed clinically (e.g., injection site reactions, bradycardia, hypoglycemia, sleep disturbances). | Through study completion (6 months) |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |