Status:
COMPLETED
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Port-wine Stain
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04106258
Start Date
May 27 2020
End Date
February 15 2023
Last Update
December 20 2023
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011