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CompletedNCT03125057Updated Aug 13, 2020

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

A Phase 4 interventional study of Hemoporfin PDT in Port-wine Stain, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 7 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
7 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Port-wine Stain
03

In context

Hemangioma, Capillary

83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.

This study's enrollment of 24 is below the median of 33 across 56 interventional studies indexed under Hemangioma, Capillary.

Browse Hemangioma, Capillary studies →

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugHemoporfin 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.

06

What researchers measure

Primary outcomes

  1. Response rate

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

    Time frame: week 8

07

Study locations

1 site
  • Beijing Children's Hospital, Capital Medical University
    Beijing, 100045, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03125057
Lead sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Aug 2, 2017
Primary completion
May 10, 2020
Completion
May 10, 2020
Last update
Aug 13, 2020

Study contacts

Lin Ma, MD
principal investigator · Bejing Children's Hospital, Capital Medical University
Jining Tao
study director · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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