A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain

Phase 4

Completed

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

• Registration Number: NCT03125057
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Brief Summary

This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2017-08-02
• Primary Completion: 2020-05-10
• Study Completion: 2020-05-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Children with clinical diagnosis of PWS；
• Age range: 7 to 14 years-old；
• Voluntarily participated and Written informed consent signed

Exclusion Criteria

• Therapy area located outside of head and neck;
• Other skin diseases that might interfere with the efficacy evaluation;
• Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
• Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
• Scar diathesis;
• Immunocompromised conditions;
• Electrocardiographic abnormalities or organic heart diseases;
• Coagulation disorders;
• 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);
• Psychiatric diseases; Severe endocrinopathies;
• 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%)

Trial Locations

Locations (1)

Beijing Children's Hospital, Capital Medical University; 🇨🇳 Beijing, China