Port-Wine Stain
Conditions
Brief summary
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.
Interventions
DRUGHemoporfin
Hemoporfin mediated photodynamic therapy
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range: 14 to 65 years-old； * Clinically diagnosed of Port-wine Stain; * Patients receiving hemoporfin based upon the clinical judgment of the investigator; * Written informed consent signed and agreed to receive periodic follow-up
Exclusion criteria
* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution; * Scar diathesis; * Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application; * Be judged not suitable to participate the study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | 96 weeks after hemoporfin application |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Response rate | 8 weeks after hemoporfin application | proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%) |
Countries
China
Outcome results
None listed