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

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Port-wine Stain

Treatments

Drug: Hemoporfin PDT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04106258

HMME-C1904

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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