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

Sichuan University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Infantile Hemangioma

Treatments: Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06798363

RCT20250123

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

low dose

Experimental group

Description:

1mg/kg/d

Treatment:

Drug: propranolol

high dose

Active Comparator group

Description:

2mg/kg/d

Treatment:

Drug: propranolol