A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters 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.
• Treatments: Hematoporphyrins

Criteria

Inclusion Criteria:

• Children with clinical diagnosis of PWS；

• ≥2 years old and <7 years old；

• The guardians agreed to voluntarily participate in this study and signed the informed consent agreement

Exclusion Criteria:

• Therapy area located outside of head and neck;

• Other skin diseases that might interfere with the efficacy evaluation;

• Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;

• Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;

• with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;

• Cicatricial constitution;

• Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;

• Electrocardiographic abnormalities or organic heart diseases;

• 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);

• Coagulation disorders;

• Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;

• Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；

• 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