Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT06875492
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2025-03-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019339', 'term': 'Port-Wine Stain'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2025-03-09', 'studyFirstSubmitQcDate': '2025-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of lesions regression', 'timeFrame': 'The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.', 'description': '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 %).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulse dye laser', 'Hemoporfin-PDT'], 'conditions': ['Port-Wine Stain']}, 'descriptionModule': {'briefSummary': '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.\n\nThe study population included patients without a history of PDL treatment and patients with a history of PDL treatment.', 'detailedDescription': '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.\n\nMethods 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\n * Patients who, after evaluation by a clinician, are deemed eligible for HMME-PDT treatment and whose guardians have signed an informed consent form.\n\n * Patients who have undergone two or more HMME-PDT treatments.\n\n ④ Patients with complete basic information and treatment-related information.\n\nExclusion Criteria:\n\n* Exclusion of patients with syndromes associated with PWS.\n\n * Exclusion of patients with a history of treatments for PWS other than PDL treatment.\n\n * Patients with other vascular malformations. ④ Exclusion of patients who have received any other PWS treatment within 2 months prior to HMME-PDT treatment.'}, 'identificationModule': {'nctId': 'NCT06875492', 'briefTitle': 'Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children', 'organization': {'class': 'OTHER', 'fullName': "Second Affiliated Hospital of Xi'an Jiaotong University"}, 'officialTitle': 'Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children', 'orgStudyIdInfo': {'id': '2024218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 (No PDL)', 'description': 'Cohort 1 (No PDL) comprised patients without a history of PDL treatment', 'interventionNames': ['Combination Product: HMME-PDT']}, {'label': 'Cohort 2 (Prior PDL)', 'description': 'Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment', 'interventionNames': ['Combination Product: HMME-PDT', 'Device: PDL']}], 'interventions': [{'name': 'HMME-PDT', 'type': 'COMBINATION_PRODUCT', 'description': 'Twice HMME-PDT, and the treatment interval is 2 to 3 months.', 'armGroupLabels': ['Cohort 1 (No PDL)', 'Cohort 2 (Prior PDL)']}, {'name': 'PDL', 'type': 'DEVICE', 'description': 'Prior PDL treatment history.', 'armGroupLabels': ['Cohort 2 (Prior PDL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710004', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Weihui Zeng', 'role': 'STUDY_CHAIR', 'affiliation': "Second Affiliated Hospital of Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Weihui Zeng', 'investigatorAffiliation': "Second Affiliated Hospital of Xi'an Jiaotong University"}}}}