Actively Recruiting
Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma: a Prospective Study
Led by West China Hospital · Updated on 2026-03-16
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infantile hemangioma (IH) is a common benign tumor in infants, affecting about 4% to 5%. While many cases resolve on their own, some develop ulcers that can cause serious complications. Researchers are evaluating how effective different starting doses of oral propranolol are in treating ulcerated IH, aiming to clarify the best dose for healing and safety in children. This study compares two doses of oral propranolol: a low dose of 1 mg per kilogram per day and a higher dose of 2 mg per kilogram per day. Children with ulcerated IH will be randomly assigned to one of these two treatment groups. The study will monitor the time it takes for ulcers to heal and observe any side effects during treatment. Participants will be followed for up to 1.5 years, during which researchers will assess ulcer healing time, the resolution of IH at six months, and any adverse events. The study involves regular evaluations to track the progress and safety of propranolol treatment. The total participation period includes treatment and follow-up assessments to understand long-term outcomes.
CONDITIONS
Brief Title
Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients with ulcerated infantile hemangioma
- Children with ulcerated infantile hemangioma treated with propranolol
You will not qualify if you...
- Children with ulcerated infantile hemangioma who received other therapeutic interventions
- Children whose families refused to participate in the study
- Patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia, and bronchial asthma
- Children lost to follow-up during oral propranolol treatment
- Children unable to take or continue oral propranolol due to other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1.5 years
Participants receive oral propranolol at either a low or high dose to treat ulcerated infantile hemangioma.
Visits scheduled according to treatment protocol for monitoring and dosing
Duration - Up to 1.5 years
Participants are monitored for ulcer healing, resolution of infantile hemangioma, and adverse events after treatment.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yi Ji
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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