Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT07058051
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Vitiligo Area Scoring Index (T-VASI)', 'timeFrame': 'At Inclusion Visit (Day 1)', 'description': 'The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease.'}, {'measure': 'Vitiligo Quality of Life Scale (VitiQoL)', 'timeFrame': 'At Inclusion Visit (Day 1)', 'description': 'The VitiQoL is an 16-item instrument assessing impact of vitiligo on quality of life. 15 items are scored on a 7-point Likert scale, ranging from "not at all" to "all the time". An additional item (not contributing to total score) assesses current severity of condition on a 7-point scale ranging from "no skin involvement" to "most severe case"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Segmental Vitiligo']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=H25-976', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the patterns of treatment, healthcare resources utilized and the burdens associated with non-segmental vitiligo (NSV) amongst participants in China\n\nThis study is a cross-sectional, multicenter, observational study of vitiligo patients in China. The cross-sectional design is sufficient to characterize the overall current burden of NSV.', 'detailedDescription': 'Cross-Sectional'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese patients with non-segmental vitiligo and 5≤T-VASI\\<50 will be included. The NSV patients will be consecutively enrolled via convenience sampling in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients, age ≥ 12.\n* Chinese patients meet the diagnosis of Non-Segmental Vitiligo (NSV) and 5≤ Total Vitiligo Area Scoring Index (T-VASI\\<50) with or without facial involvement.\n* Medical history available within the last 6 months.\n* Ability to understand the questionnaires, with parental support as required for adolescents (between ≥ 12 and \\< 18 years of age at inclusion visit).\n* Willing to provide a patient authorization form to use and disclose personal health information (or informed consent, where applicable) to participate in the study; for adolescent subjects, authorization and/or consent will be provided by a parent or legal guardian, where applicable.\n\nExclusion Criteria:\n\n* Unable or unwilling to comply with study requirements and electronic Patient-Reported Outcome (ePRO) collection.\n* Segmental or localized vitiligo.\n* Greater than 33% leukotrichia in areas of vitiligo on the face or on the body.\n* History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.\n* Patients who are participating in interventional clinical trial(s) at time of study visit.\n* Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT07058051', 'briefTitle': 'Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China', 'orgStudyIdInfo': {'id': 'H25-976'}}, 'contactsLocationsModule': {'locations': [{'zip': '510091', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Dermatology Hospital of Southern Medical University /ID# 276921', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Integrated TCM & Western Medicine Hospital（Wuhan No.1 Hospital) /ID# 276919', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '215002', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Suzhou Municipal Hospital /ID# 276948', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '250022', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Dermatological Hospital /ID# 276918', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}