Superficial infantile hemangioma
Conditions
Interventions
Ultra-early topical treatment group:Topical timolol was used as soon as the diagnosis was made
Standard topical treatment group:Topical timolol was used and started after the age of 42 days
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1.Infants diagnosed with superficial infantile hemangioma according to ISSVA criteria, regardless of sex; 2.Age less than 42 days at enrollment; 3.The legal guardian of the participant voluntarily agrees to participate in this clinical study and has signed the informed consent form; 4.No ulceration, bleeding, and/or infection on or around the hemangioma lesion, and no other local skin conditions (such as eczema, dermatitis, tinea, or other fungal skin infections);
Exclusion criteria
Exclusion criteria: 1.Participants with cutaneous hemangioma complicated by hepatic hemangioma requiring intervention as judged by the investigator; 2.Participants diagnosed with deep infantile hemangioma; 3.Participants with special types of infantile hemangioma associated with other anomalies, such as PHACE syndrome, LUMBAR (SACRAL/PELVIS) syndrome, or craniofacial hemangiomatosis; 4.Participants with superficial hemangiomas located on the lips, oral mucosa, conjunctiva, or other mucosal sites; 5.Participants with current local or systemic infection; 6.Participants or their mothers with known hypersensitivity to non-selective ß-blockers (e.g., propranolol, timolol maleate); 7.Participants with second- or third-degree atrioventricular block, bradycardia, sick sinus syndrome, cardiogenic shock, or other cardiac conditions requiring long-term medication or surgical intervention; 8.Participants requiring long-term use of CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, mirabegron); 9.Participants with a history of severe hepatic, renal, gastrointestinal, or neurological diseases; 10.Participants who have undergone any surgery within 4 weeks prior to screening or are scheduled to undergo surgery during the study period; 11.Participants with any prior history of pharmacological or non-pharmacological treatment for hemangioma before screening; 12.Participants currently enrolled in other interventional clinical trials during the screening period; 13.Participants deemed unsuitable for inclusion in this study by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment;Lesion color grading score;Proportion of patients requiring treatment modification;Treatment cure rate;Treatment cure rate;Lesion color grading score; | — |
Countries
China
Contacts
Public ContactLin Xiaoxi
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed