- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106258
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
December 18, 2023 updated by: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS)in 2-7 years old children.
The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaoxi Lin, MD
- Phone Number: +86-21-23271699
- Email: linxiaoxi@126.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200011
- Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children with clinical diagnosis of PWS;
- ≥2 years old and <7 years old;
- The guardians agreed to voluntarily participate in this study and signed the informed consent agreement
Exclusion Criteria:
- Therapy area located outside of head and neck;
- Other skin diseases that might interfere with the efficacy evaluation;
- Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;
- Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;
- with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;
- Cicatricial constitution;
- Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;
- Electrocardiographic abnormalities or organic heart diseases;
- 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);
- Coagulation disorders;
- Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;
- Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia;
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low light dose
PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
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Photodynamic therapy is performed using hemoporfin under general anesthesia.
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.
|
Experimental: high light dose
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
|
Photodynamic therapy is performed using hemoporfin under general anesthesia.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: week 8
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proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
|
week 8
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Incidence of adverse events and adverse reactions
Time Frame: up to 24 weeks after the treatment
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up to 24 weeks after the treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2020
Primary Completion (Actual)
February 15, 2023
Study Completion (Actual)
February 15, 2023
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMME-C1904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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