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The Clinical Efficacy of Propranolol Combined with Sclerotherapy versus Propranolol for Infantile Hemangiomas: A Multicenter, Prospective, Randomized Controlled Clinical Trial

The Clinical Efficacy of Propranolol Combined with Sclerotherapy versus Propranolol for Infantile Hemangiomas: A Multicenter, Prospective, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096881
Enrollment
Unknown
Registered
2025-02-08
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Infantile Hemangiomas

Interventions

Group A:Propranolol Combined with Sclerotherapy
Group B:Oral propranolol

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.According to ISSVA guideline (2018 version), the patients are diagnosed with deep-type and/or mixed-type hemangiomas and are under 12 months old. 2.There is no ulceration, bleeding, and/or infection on the surface and around the tumor body, and there are no other local skin diseases (such as eczema, dermatitis, tinea corporis, or other skin fungal infections, etc.). 3.Physical examinations, vital signs, laboratory, and auxiliary examinations during the screening period are judged by the researchers to meet the requirements of the trial.

Exclusion criteria

Exclusion criteria: 1. Birth weight less than 2.5 kg and age less than 1 month at screening (including premature infants with corrected gestational age less than 1 month); 2. Abdominal ultrasound indicates cutaneous hemangioma combined with hepatic hemangioma; 3.Special types of infantile hemangiomas associated with other pathologies, such as PHACE syndrome, LUMAR (SACRAL/PELVIS) syndrome; 4.Children with superficial infantile hemangiomas occurring on oral mucosa or conjunctiva; 5.Presence of contraindications related to propranolol, such as asthma, abnormal blood pressure or heart rate, sick sinus syndrome, endocrine system diseases like pheochromocytoma, drugs that interact with propranolol; recent or ongoing hypoglycemic episodes; second - degree or third - degree atrioventricular block; allergy to propranolol or any other components in it. 6.Contraindications related to sclerosing injection therapy, such as allergy to sclerosing agents, individuals with severe allergic constitution, those with obvious ulceration and infection; patients with poor general condition: such as those with severe cardiac insufficiency; those with severe coagulation disorders; 7.History of receiving drug treatment for hemangiomas.

Design outcomes

Primary

MeasureTime frame
Erythema assessment grading scale score;Criteria for qualitative assessment of hemangiomas;

Countries

China

Contacts

Public ContactLiu Xiaoliang/Hu Fan

West China Second University Hospital, Sichuan University

hufan@scu.edu.cn+86 136 7812 2589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026