Actively Recruiting

Phase 2
Phase 3
Age: 1Month - 4Years
All Genders
ID06798363

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

Age: 1Month - 4Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients with ulcerated infantile hemangioma
  • Children with ulcerated infantile hemangioma treated with propranolol
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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