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The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.
Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superficial Group | Hemangioma depth evaluated by B-ultrasonoscope is lower than or equal to 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. |
| |
| Deep Group | Hemangioma depth evaluated by B-ultrasonoscope is more than 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate 0.5% Oph Soln | Drug | External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depth of infantile hemangioma | At the beginning of treatment, the thickness of hemangioma was measured by b-mode ultrasound at each follow-up. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Color | The redness of lesion is measured by standard photography. | through study completion, an average of 1 year |
| Dimensions | The dimension of lesion is measured by standard photography. |
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Inclusion Criteria:
Exclusion Criteria:
periorbital and lip IHs.
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Patients with infantile hemangiomas presented to the outpatient clinic of Shanghai Ninth People's Hospital would be considered for enrolment in the study. The diagnosis of proliferating infantile hemangioma is based on medical history and B-ultrasonography.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XiaoXi Lin, PhD | Contact | 021-23271699 | linxiaoxi@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Lin, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| through study completion, an average of 1 year |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |