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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125057
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Port-wine Stain Drug: Hemoporfin PDT Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : May 10, 2020

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
Drug: Hemoporfin PDT
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.

Experimental: high light dose
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
Drug: Hemoporfin PDT
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 Measures :
  1. Response rate [ Time Frame: week 8 ]
    proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125057


Locations
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China
Beijing Children's Hospital, Capital Medical University
Beijing, China, 100045
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Lin Ma, MD Bejing Children's Hospital, Capital Medical University
Study Director: Jining Tao Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03125057    
Other Study ID Numbers: HMME-C1610
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma, Capillary
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms