Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children

Xi'an Jiaotong University

Status

Completed

Conditions

Port-Wine Stain

Treatments

Device: PDL

Combination Product: HMME-PDT

Study type

Observational

Funder types

Other

Identifiers

NCT06875492

2024218

Details and patient eligibility

About

This retrospective study investigated the influence of prior pulse dye laser (PDL) treatment on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.

The study population included patients without a history of PDL treatment and patients with a history of PDL treatment.

Full description

Background Hemoporfin-mediated photodynamic therapy (Hemoporfin-PDT) is considered a safe and effective treatment for port-wine stains (PWS). This study aims to investigate the influence of prior pulse dye laser (PDL) treatments history on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.

Methods Data was gathered for individuals with PWS aged 1-3 years who received two or more Hemoporfin-PDT treatments. The study population was stratified into two groups: Cohort 1 (No PDL) comprised patients without a history of PDL treatment, while Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment. An analysis was conducted to investigate the relationship between treatment efficacy and variables including gender, age, location, and type of PWS.

Enrollment

273 patients

Sex

All

Ages

1 to 3 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients clinically diagnosed with PWS (Port Wine Stain) who were between 1 and 3 years old at the time of their first HMME-PDT treatment.
- Patients who, after evaluation by a clinician, are deemed eligible for HMME-PDT treatment and whose guardians have signed an informed consent form.
  - Patients who have undergone two or more HMME-PDT treatments.
    
    ④ Patients with complete basic information and treatment-related information.

Exclusion criteria

Exclusion of patients with syndromes associated with PWS.
- Exclusion of patients with a history of treatments for PWS other than PDL treatment.
  - Patients with other vascular malformations. ④ Exclusion of patients who have received any other PWS treatment within 2 months prior to HMME-PDT treatment.