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

• Status: Completed
• Trial end date: 2020-05-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Criteria

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