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This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoporfin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoporfin | Drug | Hemoporfin mediated photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | 96 weeks after hemoporfin application |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction rating of the overall treatment by subjects | 8, 24 and 96 weeks after hemoporfin application | |
| Satisfaction rating of the overall treatment by investigators | 8 weeks after hemoporfin application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuejun Zhu | Peking University First Hospital | Principal Investigator |
| Jining Tao | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |||
| Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C494379 | hematoporphyrin monomethyl ether |
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| Response rate | proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%) | 8 weeks after hemoporfin application |
| Shijiazhuang |
| Herbei |
| China |
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Peking University First Hospital | Beijing | 100034 | China |
| PLA Army General Hospital | Beijing | China |
| Shanghai Dermatology Hospital | Shanghai | China |
| D017437 | Skin and Connective Tissue Diseases |