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

NCT ID: NCT06875492

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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

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Port-Wine Stain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1 (No PDL)

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

HMME-PDT

Intervention Type COMBINATION_PRODUCT

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

HMME-PDT

Intervention Type COMBINATION_PRODUCT

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

PDL

Intervention Type DEVICE

Prior PDL treatment history.

Interventions

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HMME-PDT

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

Intervention Type COMBINATION_PRODUCT

PDL

Prior PDL treatment history.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Weihui Zeng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weihui Zeng

Role: STUDY_CHAIR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

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The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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2024218

Identifier Type: -

Identifier Source: org_study_id

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