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

NCT03125057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-08-13

No results posted yet for this study

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.

Conditions

  • Port-wine Stain

Interventions

DRUG

Hemoporfin PDT

Photodynamic therapy is performed using hemoporfin. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Lin Ma, MD · Bejing Children's Hospital, Capital Medical University

  • Jining Tao · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2020-05-10
Completion
2020-05-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125057 on ClinicalTrials.gov