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A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106258
Recruitment Status : Recruiting
First Posted : September 27, 2019
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 (2-7 Years Old) With Port-wine Stain
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

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 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
Drug: Hemoporfin PDT
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 Measures :
  1. Response rate [ Time Frame: week 8 ]
    proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)

  2. Incidence of adverse events and adverse reactions [ Time Frame: up to 24 weeks after the treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04106258


Contacts
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Contact: Xiaoxi Lin, MD +86-21-23271699 linxiaoxi@126.com

Locations
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China, Shanghai
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200011
Contact: Mochi Liu    +86-21-23271699 ext 5576    shjyiec@126.com   
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04106258    
Other Study ID Numbers: HMME-C1904
First Posted: September 27, 2019    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