Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma

NCT06798363 | Recruiting Phase 2

• 1 other identifier: RCT20250123
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).

Conditions

Infantile Hemangioma

Keywords

Infantile hemangioma, ulcer, propranolol

Outcome Measures

Primary Outcomes (1)

• Time to ulcer healing

  Time from the start of treatment with propranolol to complete ulcer healing

  0.5 years

Secondary Outcomes (2)

• The resolution of IH at month 6 after treatment

  0.5 years

• adverse events

  0.5 years

Study Arms (2)

low dose

EXPERIMENTAL

1mg/kg/d

Drug: propranolol

high dose

ACTIVE COMPARATOR

2mg/kg/d

Drug: propranolol

Interventions

propranolol DRUG

different dose

high dose; low dose

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all patients with ulcer IH;
• children with ulcer IH treated with propranolol.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (3)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Women and Children's Hospital

Chengdu, Sichuan, 610045, China

RECRUITING

West China Second University Hospital of Sichuan University

Chengdu, Sichuan, 610066, China

RECRUITING

MeSH Terms

Conditions

Hemangioma, Capillary; Ulcer

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Yi Ji

CONTACT

+862885423453; jijiyuanyuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)