Clinical Trial: A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain

Brief Summary: This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.

Detailed Summary:
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Current Primary Outcome: Response rate [ Time Frame: week 8 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Dates:
Date Received: April 19, 2017
Date Started: May 2017
Date Completion: December 2017
Last Updated: April 24, 2017
Last Verified: April 2017