Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Phase 4CompletedNCT03181984

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.501 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

501

Conditions

Port-Wine Stain

Interventions

HemoporfinDRUG

Hemoporfin mediated photodynamic therapy

Eligibility

Sex: ALLMin age: 14 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine

Shijiazhuang, Herbei, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events

Time frame: 96 weeks after hemoporfin application

Secondary Outcomes

Satisfaction rating of the overall treatment by subjects

Time frame: 8, 24 and 96 weeks after hemoporfin application

Satisfaction rating of the overall treatment by investigators

Time frame: 8 weeks after hemoporfin application

Response rate

proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)

Time frame: 8 weeks after hemoporfin application

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.