NCT03125057CompletedPhase 4
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.1 site in 1 country24 target enrollmentStarted: August 2, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
low light dose
Experimental
PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
Intervention: Hemoporfin PDT (Drug)
high light dose
Experimental
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
Intervention: Hemoporfin PDT (Drug)
Outcomes
Primary Outcomes
Response rate
Time Frame: week 8
proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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