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

Port-wine Stain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106258
• Other study ID #: HMME-C1904
• Status: Completed
• Phase: Phase 4
• Start date: May 27, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: December 2023
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)	week 8
Primary	Incidence of adverse events and adverse reactions		up to 24 weeks after the treatment