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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06875492
Enrollment
273
Registered
2025-03-13
Start date
2024-04-01
Completion date
2024-09-01
Last updated
2025-03-13

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

Conditions

Port-Wine Stain

Keywords

Pulse dye laser, Hemoporfin-PDT

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.

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.

Interventions

COMBINATION_PRODUCTHMME-PDT

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

DEVICEPDL

Prior PDL treatment history.

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of lesions regressionThe efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.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 %).

Countries

China

Outcome results

None listed

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