ClinicalTrials.gg
RecruitingNCT06798363Updated Sep 21, 2026

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

A Phase 2/3 interventional study of propranolol in Infantile Hemangioma, sponsored by West China Hospital. Recruiting at 3 sites in China. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by West China Hospital · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
Up to 1 Year
Sex
All
01

Study 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).

Read the detailed description

Infantile hemangioma (IH) is the most common benign tumor in infants, with an estimated prevalence of 4%-5%. Although most IH resolves over time without serious sequelae, a significant proportion can lead to serious complications such as ulcers. Propranolol is considered to be an effective treatment modality for ulceration IH, and there are retrospective studies suggesting that starting treatment at a low dose is safe and effective. However, due to the lack of prospective study, the effectiveness of different doses of propranolol for initiating treatment of ulceration IH is unknown. Therefore, a prospective study of ulceration IHs in Chinese children was conducted to clarify its efficacy.

02

Conditions studied

  • Infantile Hemangioma

Keywords

  • Infantile hemangioma, ulcer, propranolol
03

In context

Hemangioma, Capillary

33 studies on the registry are indexed under Hemangioma, Capillary; 5 are open to participants now.

This study's planned enrollment of 32 is below the median of 78 across 20 interventional studies indexed under Hemangioma, Capillary.

Browse Hemangioma, Capillary studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    low dose

    1mg/kg/d

    Drug: propranolol

  • Active comparator
    high dose

    2mg/kg/d

    Drug: propranolol

Interventions

06

What researchers measure

Primary outcomes

  1. Time to ulcer healing

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

    Time frame: 0.5 years

Secondary outcomes

  1. The resolution of IH at month 6 after treatment

    complete resolution/complete resolution/partial resolution/no effect/withdrawal from treatment

    Time frame: 0.5 years

  2. adverse events

    The incidence of adverse events in the two groups after oral propranolol at different doses

    Time frame: 0.5 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Sep 2026, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2025
First posted
Jan 29, 2025
StartActual
Jan 1, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Mar 30, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06798363
Responsible party
Yi Ji (Doctor, West China Hospital) — Principal investigator
First posted
Jan 29, 2025
Start date
Jan 1, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Yi Ji
Contact
jijiyuanyuan@163.com
+862885423453

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Propranolol

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