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NCT Number: NCT03125057

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

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.

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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

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with clinical diagnosis of PWS；
  • Age range: 7 to 14 years-old；
  • Voluntarily participated and Written informed consent signed

Exclusion criteria

  • Therapy area located outside of head and neck;
  • Other skin diseases that might interfere with the efficacy evaluation;
  • Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
  • Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
  • Scar diathesis;
  • Immunocompromised conditions;
  • Electrocardiographic abnormalities or organic heart diseases;
  • Coagulation disorders;
  • Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN);
  • Psychiatric diseases; Severe endocrinopathies;
  • Previous therapy of PWS within the last 4 weeks;
  • Participation in any clinical studies within the last 4 weeks;
  • Be judged not suitable to participate the study by the investigators

Treatment and study plan

Hemoporfin PDT

Drug

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.

Primary outcomes

  1. Response rate

    Time frame: week 8

    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

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Aug 13, 2020

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.

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