An observational study in Port-Wine Stain, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Observational
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.
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.
83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.
This study's enrollment of 273 is above the median of 143 across 18 observational studies indexed under Hemangioma, Capillary.
Browse Hemangioma, Capillary studies →Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 68 studies on the registry; 15 are open to participants now.
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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.
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.
Cohort 1 (No PDL) comprised patients without a history of PDL treatment
Combination Product: HMME-PDT
Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment
Combination Product: HMME-PDT · Device: PDL
Twice HMME-PDT, and the treatment interval is 2 to 3 months.
Prior PDL treatment history.
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 %).
Time frame: The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Xi'an Jiaotong University