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

Phase 4

Completed

• Conditions: Port-wine Stain
• Interventions: Drug: Hemoporfin PDT

• Registration Number: NCT04106258
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2020-05-27
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
low light dose	Hemoporfin PDT	PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
high light dose	Hemoporfin PDT	PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China