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

NCT06875492 | Completed

• 1 other identifier: 2024218
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Port-Wine Stain

Keywords

Pulse dye laser; Hemoporfin-PDT

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Cohort 1 (No PDL)

Cohort 1 (No PDL) comprised patients without a history of PDL treatment

Combination Product: HMME-PDT

Cohort 2 (Prior PDL)

Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment

Combination Product: HMME-PDT; Device: PDL

Interventions

HMME-PDT COMBINATION_PRODUCT

Twice HMME-PDT, and the treatment interval is 2 to 3 months.

Cohort 1 (No PDL); Cohort 2 (Prior PDL)

PDL DEVICE

Prior PDL treatment history.

Cohort 2 (Prior PDL)

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: April 1, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)