Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Port-Wine Stain Clinical Trial

Official title:

Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181984
• Other study ID #: HMME-S1612
• Status: Completed
• Phase: Phase 4
• Start date: August 31, 2017
• Est. completion date: April 19, 2023

Study information

• Verified date: December 2023
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• Hemoporfin
Hemoporfin mediated photodynamic therapy

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing
China	PLA Army General Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shanghai Dermatology Hospital	Shanghai
China	Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine	Shijiazhuang	Herbei
China	Wuxi People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events		96 weeks after hemoporfin application
Secondary	Satisfaction rating of the overall treatment by subjects		8, 24 and 96 weeks after hemoporfin application
Secondary	Satisfaction rating of the overall treatment by investigators		8 weeks after hemoporfin application
Secondary	Response rate	proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)	8 weeks after hemoporfin application