Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

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 Overview

• Status: Completed
• Conditions: Port-Wine Stain
• Intervention / Treatment: Drug: Hemoporfin

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China
    • PLA Army General Hospital
  • Shanghai, China
    • Shanghai Dermatology Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The 2nd Affiliated Hospital of Harbin Medical University
  • Herbei
    • Shijiazhuang, Herbei, China
      • Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemoporfin	Drug: Hemoporfin; Hemoporfin mediated photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events	96 weeks after hemoporfin application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)	8 weeks after hemoporfin application

Collaborators and Investigators

• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xuejun Zhu, Peking University First Hospital; Study Director: Jining Tao, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Hemangioma; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain
• Other Study ID Numbers: HMME-S1612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No