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

NCT ID: NCT03125057

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-02
• Study Completion Date: 2020-05-10

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.

Conditions

Port-wine Stain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

low light dose

PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes

Group Type: EXPERIMENTAL

Hemoporfin PDT

Intervention Type: DRUG

Photodynamic therapy is performed using hemoporfin. 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.

high light dose

PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes

Group Type: EXPERIMENTAL

Hemoporfin PDT

Intervention Type: DRUG

Photodynamic therapy is performed using hemoporfin. 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.

Interventions

Hemoporfin PDT

Photodynamic therapy is performed using hemoporfin. 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Bejing Children's Hospital, Capital Medical University

Jining Tao

Role: STUDY_DIRECTOR

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

HMME-C1610

Identifier Type: -

Identifier Source: org_study_id