Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
NCT ID: NCT03181984
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
501 participants
INTERVENTIONAL
2017-08-31
2023-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hemoporfin
Hemoporfin
Hemoporfin mediated photodynamic therapy
Interventions
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Hemoporfin
Hemoporfin mediated photodynamic therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
65 Years
ALL
No
Sponsors
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xuejun Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Jining Tao
Role: STUDY_DIRECTOR
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Locations
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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
Peking University First Hospital
Beijing, , China
PLA Army General Hospital
Beijing, , China
Shanghai Dermatology Hospital
Shanghai, , China
Countries
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Other Identifiers
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HMME-S1612
Identifier Type: -
Identifier Source: org_study_id