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A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain

Primary Purpose

Port-wine Stain

Status
Active
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

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

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%)
Incidence of adverse events and adverse reactions

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
February 13, 2023
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04106258
Brief Title
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
Official Title
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

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 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.

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
40 (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 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.
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
Title
Incidence of adverse events and adverse reactions
Time Frame
up to 24 weeks after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain

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