Different starting doses of oral propranolol for ulcerated infantile hemangioma

Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma： a Prospective Study

This trial sees if different starting doses of oral propranolol help heal ulcerated infantile hemangiomas and are safe for infants.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Month to 4 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06798363 on ClinicalTrials.gov

What this trial studies

This phase 2/3 interventional study prospectively compares different initial oral propranolol doses in children with ulcerated infantile hemangiomas. Participants receive propranolol and are followed for ulcer healing, treatment-related complications, and adverse events. Children who previously received other interventions or who have contraindications to propranolol are excluded. The aim is to clarify which starting dose offers effective ulcer healing with the fewest side effects.

Who should consider this trial

Good fit: Infants and young children with ulcerated infantile hemangioma who can take oral propranolol and have no propranolol contraindications are ideal candidates.

Not a fit: Children who have already received other treatments for the ulcer, who cannot tolerate or are contraindicated for propranolol, or who cannot complete follow-up may not benefit from this study.

Why it matters

Potential benefit: If successful, the study could identify a starting propranolol dose that speeds ulcer healing while minimizing side effects for affected infants.

How similar studies have performed: Propranolol is an established treatment for infantile hemangioma and retrospective reports suggest low starting doses can be effective and safe, but prospective dose-comparison data are limited.

Eligibility criteria

Inclusion Criteria:

1. all patients with ulcer IH;
2. children with ulcer IH treated with propranolol.

Exclusion Criteria:

1\) children with ulcer IH who received other therapeutic interventions were excluded; 2) Children whose families refused to participate in the study; 3) patients with contraindications to oral propranolol, such as allergy to propranolol, severe bradycardia and bronchial asthma; 4) children lost to follow-up during oral propranolol treatment; 5) children unable to oral propranolol or continue to oral propranolol due to other reasons.

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Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yi Ji

Conditions Infantile Hemangioma; Infantile hemangioma, ulcer, propranolol