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

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Port-wine Stain

Treatments

Drug: Hemoporfin PDT

Study type

Interventional

Funder types

Industry

Identifiers

NCT03125057

HMME-C1610

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

7 to 14 years old

Volunteers

No Healthy Volunteers

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