Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01082393
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2010-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2010-02-26', 'studyFirstSubmitQcDate': '2010-03-05', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of skin pigmentation in the treated area', 'timeFrame': 'after 1 day, 10 days, 30 days and 60 days', 'description': 'digital image analysis system for surface measurement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitiligo'], 'conditions': ['Vitiligo']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female,\n* Age 18-70 years,\n* Extensive vitiligo (\\> 50% body surface area),\n* Patients asking for depigmenting therapy,\n* Not pregnant.\n\nExclusion Criteria:\n\n* Children,\n* Non extensive vitiligo (\\< 50% boy surface area),\n* Patients not asking for depigmenting therapies,\n* Pregnant.'}, 'identificationModule': {'nctId': 'NCT01082393', 'acronym': 'Koebner', 'briefTitle': 'Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)', 'orgStudyIdInfo': {'id': '2009/599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'topical tacrolimus', 'interventionNames': ['Drug: topical tacrolimus treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'topical pimecrolimus', 'interventionNames': ['Drug: topical pimecrolimus treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'local steroids', 'interventionNames': ['Drug: local mometasone furoate treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cold cream', 'interventionNames': ['Drug: cold cream']}], 'interventions': [{'name': 'topical tacrolimus treatment', 'type': 'DRUG', 'description': '4 applications (day 1,day 3, day 6 and day10)', 'armGroupLabels': ['topical tacrolimus']}, {'name': 'topical pimecrolimus treatment', 'type': 'DRUG', 'description': '4 applications (day 1, day 3, day 6 and day 10)', 'armGroupLabels': ['topical pimecrolimus']}, {'name': 'local mometasone furoate treatment', 'type': 'DRUG', 'description': '4 applications (day 1, day 3, day 6 and day 10)', 'armGroupLabels': ['local steroids']}, {'name': 'cold cream', 'type': 'DRUG', 'description': '4 applications (day 1, day 3, day 6 and day 10)', 'armGroupLabels': ['cold cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Nanny Van Geel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}