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

Phase 2

Not yet recruiting

• Conditions: Infantile Hemangioma
• Interventions: Drug: propranolol

• Registration Number: NCT06798363
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-04-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose	propranolol	1mg/kg/d
high dose	propranolol	2mg/kg/d

Primary Outcome Measures

Name	Time	Method
Time to ulcer healing	1.5 years	Time from the start of treatment with propranolol to complete ulcer healing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China