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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06798363

Enrollment

Registered

2025-01-29

Start date

2025-05-02

Completion date

2026-08-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Hemangioma

Keywords

Infantile hemangioma, ulcer, propranolol

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).

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.

Interventions

DRUGpropranolol

different dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 4 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Time to ulcer healing	1.5 years	Time from the start of treatment with propranolol to complete ulcer healing

Secondary

Measure	Time frame	Description
The resolution of IH at month 6 after treatment	1.5 years	complete resolution/complete resolution/partial resolution/no effect/withdrawal from treatment
adverse events	1.5 years	The incidence of adverse events in the two groups after oral propranolol at different doses

Countries

China

Contacts

CONTACTYi Ji

jijiyuanyuan@163.com+862885423453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026