A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain (NCT04106258) | Clinical Trial Compass
CompletedPhase 4
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
China40 participantsStarted 2020-05-27
Plain-language 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.
Who can participate
Age range2 Years – 6 Years
SexALL
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Inclusion Criteria:
* Children with clinical diagnosis of PWSï¼›
* ≥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 evalua…