NCT06875492

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 273 (actual)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Port-Wine Stain

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HMME-PDT	Twice HMME-PDT, and the treatment interval is 2 to 3 months.
DEVICE	PDL	Prior PDL treatment history.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-20
• Completion: 2024-09-01
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: China