A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||2 Years - 6 Years|
- - 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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: low light dose
PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
Experimental: high light dose
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
Drug: - Hemoporfin 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.
Contact a Trial Team
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Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, 200011