CompletedNot Applicable

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

China260 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range12 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical Therapeutic Effect

Timeframe: 6 Months

Trial details

NCT IDNCT07104526

SponsorWuhan Integrated Traditional Chinese and Western Medicine Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Infantile Hemangioma (IH) trials