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

Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04106258
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
28.2
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hemoporfin PDT
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Response rate [week 8]

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

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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Shanghai Shanghai China 200011

Sponsors and Collaborators

  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04106258
Other Study ID Numbers:
  • HMME-C1904
First Posted:
Sep 27, 2019
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemangioma, Capillary
Port-Wine Stain

Study Results

No Results Posted as of Mar 16, 2022