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

Port-wine Stain Clinical Trial

Official title:

A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125057
• Other study ID #: HMME-C1610
• Status: Completed
• Phase: Phase 4
• Start date: August 2, 2017
• Est. completion date: May 10, 2020

Study information

• Verified date: August 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing

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