Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

HMME-S1612

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.

2017-08-31

2023-04-19

2023-04-19

Completed

Early phase I

501

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 501, 'type': 'ACTUAL'}}

2023-12-20