Port-wine Stain
Conditions
Brief 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.
Interventions
DRUGHemoporfin PDT
Photodynamic therapy is performed using hemoporfin under general anesthesia. 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
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | week 8 | proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%) |
| Incidence of adverse events and adverse reactions | up to 24 weeks after the treatment | — |
Countries
China
Outcome results
None listed