NCT06798363

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
3mo left

Started May 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
May 2025Aug 2026

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

January 23, 2025

Last Update Submit

March 13, 2026

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

    1.5 years

Secondary Outcomes (2)

  • The resolution of IH at month 6 after treatment

    1.5 years

  • adverse events

    1.5 years

Study Arms (2)

low dose

EXPERIMENTAL

1mg/kg/d

Drug: propranolol

high dose

ACTIVE COMPARATOR

2mg/kg/d

Drug: propranolol

Interventions

propranololDRUG

different dose

high doselow dose

Eligibility Criteria

Age1 Month - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hemangioma, CapillaryUlcer

Interventions

Propranolol

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Central Study Contacts

Yi Ji

CONTACT

+862885423453jijiyuanyuan@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
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

May 2, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)