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

Primary Purpose

Port-wine Stain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hemoporfin PDT
Sponsored by
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-wine Stain

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Beijing Children's Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

low light dose

high light dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Response rate
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)

Secondary Outcome Measures

Full Information

First Posted
April 19, 2017
Last Updated
August 12, 2020
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03125057
Brief Title
A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain
Official Title
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-wine Stain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low light dose
Arm Type
Experimental
Arm Description
PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
Arm Title
high light dose
Arm Type
Experimental
Arm Description
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
Intervention Type
Drug
Intervention Name(s)
Hemoporfin PDT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Description
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Ma, MD
Organizational Affiliation
Bejing Children's Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jining Tao
Organizational Affiliation
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100045
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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