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This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS)in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low light dose | Experimental | PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes |
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| high light dose | Experimental | PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoporfin PDT | Drug | Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin(5mg/kg)is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%) | week 8 |
| Incidence of adverse events and adverse reactions | up to 24 weeks after the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
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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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| D017437 | Skin and Connective Tissue Diseases |