Infantile hemangioma
Conditions
Interventions
Oral Propranolol Treatment Group:Oral propranolol liquid daily, 2mg/kg*d, twice a day, for at least six months until complete remission
Topical Betamethasone Injection Treatment Group:Monthly injections of compound betamethasone solution, no more than 1ml per injection and no more than 6 injections
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 0.5 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 30 to 180 days old, regardless of gender; 2. Patients with a clear diagnosis of infantile hemangioma with medical history, clinical presentation and imaging (ultrasound or CT or MRI); 3. Patients with the maximum diameter of a single hemangioma less than 3 cm; 4. Patients whose appearance is significantly affected by the hemangioma and is at risk of disfigurement; 5. Patients whose guardians understand the study content and treatment risks, sign an informed consent form and are willing to cooperate with the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to the components of propranolol, timolol maleate, or other beta-blockers, or who have a history of severe allergy; 2. Patients who have been previously given systemic, intra-focal or topical corticosteroids, vincristine, alpha-interferon, imiquimod, or other beta-blockers; 3. Patients whose mother has been breastfeeding them during treatment with beta-blockers, systemic (oral, intravenous or intramuscular) corticosteroids, vincristine or alpha-interferon; 4. Patients born more than 2 months prematurely or less than 60 days old; 5. Patients who have received any treatment for hemangioma (including surgery, hormonal drugs and laser treatment); 6. Patients with ulcers on the surface of the tumor; 7. Patients with other skin diseases such as eczema or milk moss on the surface of the tumor or surrounding skin; 8. Patients with atrioventricular block of degree II or higher, bradycardia (heart rate <100 bpm), sinus node syndrome, cardiogenic shock or other congenital heart disease; 9. Patients with respiratory diseases such as bronchial asthma, bronchospasm, pneumonia, etc.; 10. Patients with central nervous system diseases; or symptoms of increased intracranial pressure; or a combination of other conditions that could potentially cause or exacerbate hemangiomas in infants and children; 11. Patients who have a blood pressure < 50 mmHg systolic or < 30 mmHg diastolic; 12. Patients who have received any other study drug within 4 weeks prior to screening; 13. Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemangioma volume;Adverse events and incidence; | — |
Countries
China
Contacts
Public ContactYajing Qiu
Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed