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

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.

Study Overview

• Status: Completed
• Conditions: Port-Wine Stain
• Intervention / Treatment: Combination product: HMME-PDT; Device: PDL

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.

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This cohort study is a retrospective, single-center study based on a database established by the photodynamic therapy team at the Second Affiliated Hospital of Xi'an Jiaotong University.We defined "young children" as children aged 1 to 3 years. This research encompassed young children who had undergone two or more sessions of Hemoporfin-PDT. Data on gender, age, medical history, type of PWS, lesion location, and post-treatment efficacy were collected following two rounds of Hemoporfin-PDT.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (No PDL); Cohort 1 (No PDL) comprised patients without a history of PDL treatment	Combination product: HMME-PDT; Twice HMME-PDT, and the treatment interval is 2 to 3 months.
Cohort 2 (Prior PDL); Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment	Combination product: HMME-PDT; Twice HMME-PDT, and the treatment interval is 2 to 3 months.; Device: PDL; Prior PDL treatment history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of lesions regression	Two independent blinded assessors assessed treatment efficacy by comparing before and after treatment photos of patients receiving Hemoporfin-PDT for reducing redness. The final outcome was determined as the average of these two assessments. Efficacy was assessed using standard quartiles: Excellent (76-100 %); Good (51-75 %); Fair (26-50 %); Poor (0-25 %).	The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Investigators: Study Chair: Weihui Zeng, Second Affiliated Hospital of Xi'an JiaoTong University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: March 9, 2025
• First Submitted That Met QC Criteria: March 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pulse dye laser; Hemoporfin-PDT
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Congenital Abnormalities; Neoplasms, Vascular Tissue; Skin Abnormalities; Hemangioma; Hemangioma, Capillary; Port-Wine Stain
• Other Study ID Numbers: 2024218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No