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

NCT03125057 | Completed Phase 4

• 1 other identifier: HMME-C1610
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Port-wine Stain

Outcome Measures

Primary Outcomes (1)

• Response rate

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

  week 8

Study Arms (2)

low light dose

EXPERIMENTAL

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

Drug: Hemoporfin PDT

high light dose

EXPERIMENTAL

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

Drug: Hemoporfin PDT

Interventions

Hemoporfin PDT DRUG

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.

high light dose; low light dose

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with clinical diagnosis of PWS；
• Age range: 7 to 14 years-old；
• Voluntarily participated and Written informed consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lin Ma, MD

  Bejing Children's Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

• Jining Tao

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: August 2, 2017
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)