Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 12:47 PM
Study NCT ID:
NCT04966533
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2021-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterize Metzker Pigmentary Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metzker pigmentary disorder pattern', 'timeFrame': '1 day', 'description': 'Plume of smoke/ Cloud/Flag/ Linear'}], 'secondaryOutcomes': [{'measure': 'Rate of Evolution', 'timeFrame': '1 day', 'description': 'Stability/ partial regression/aggravation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metzker pigmentary disorder'], 'conditions': ['Pigment Dispersion', 'Mosaicism']}, 'descriptionModule': {'briefSummary': "Metzker pigmentary disorders are frequent cause of consultation in pediatric dermatology. The investigators can describe 4 patterns. They must be differentiated from mosaicisms because they aren't associated with neurologic disorders and don't require any follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children coming at the pediatric dermatology consultation with a Metkzer pigmentary disorder between 2005 and 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Metzker pigmentary disorder, age between birth and 18 years old\n\nExclusion criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04966533', 'briefTitle': 'Characterize Metzker Pigmentary Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Characterize Metzker Pigmentary Disorders', 'orgStudyIdInfo': {'id': 'RECHMPL21_0383'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Didier BESSIS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}