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

A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03125057

Enrollment

Registered

2017-04-24

Start date

2017-08-02

Completion date

2020-05-10

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port-wine Stain

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.

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response rate	week 8	proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026