Skip to main content
OpenTrials
Completed

NCT Number: NCT03181984

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Port-Wine Stain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemoporfin

Drug

Hemoporfin mediated photodynamic therapy

Primary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 96 weeks after hemoporfin application

Secondary outcomes

  1. Satisfaction rating of the overall treatment by subjects

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

  2. Satisfaction rating of the overall treatment by investigators

    Time frame: 8 weeks after hemoporfin application

  3. Response rate

    Time frame: 8 weeks after hemoporfin application

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2017
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.