Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-02 @ 9:08 AM
Study NCT ID:
NCT02104960
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2014-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Skin Parameters in the PROOF Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D018613', 'term': 'Microscopy, Confocal'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Skin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCINEXA score', 'timeFrame': 'Day 1', 'description': 'The aging of the skin is evaluated by a semi-quantitative composite of 19 clinical variables : the score SCINEXA'}], 'secondaryOutcomes': [{'measure': 'in vivo confocal microscopy', 'timeFrame': 'Day 1', 'description': 'Skin aging evaluated by in vivo confocal microscopy'}, {'measure': 'ex vivo confocal microscopy', 'timeFrame': 'Day 1', 'description': 'Skin aging evaluated by ex vivo confocal microscopy ( thickness of the epidermis with and without the stratum corneum, dermis thickness , number of sweat glands per unit volume).'}, {'measure': 'histology', 'timeFrame': 'Day 1', 'description': 'Skin aging evaluated by conventional histology (thickness of the epidermis and dermis, presence and degree of elastosis , flattening of the dermo- epidermal junction)'}, {'measure': 'RAMAN', 'timeFrame': 'Day 1', 'description': 'The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin Surface Microscopy', 'Skin Aging', 'PROOF'], 'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate skin aging of an homogeneous population of 77 years old patient selected among the PROOF cohort who has been continuously investigated by cardiological examination.\n\nSkin aging will be explored by macroscopic and microscopic evaluation. In particular, skin aging will be measured by an index of clinical aging (SCINEXA) and other complementary measures such as facial photos, standard and High Definition dermoscopy, elastography, sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PROOF cohort (NCT00759304)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* included in the PROOF cohort\n* Form consent signed\n\nExclusion Criteria:\n\n* Past history of surgery and / or treatment of aesthetic medicine\n* neurological disorders\n* insulin-dependent diabetes,\n* corticosteroids or retinoids (isotretinoin, ...) \\> 1 year'}, 'identificationModule': {'nctId': 'NCT02104960', 'acronym': 'PEAU PROOF', 'briefTitle': 'Study of Skin Parameters in the PROOF Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Study of Skin Parameters in the PROOF Cohort', 'orgStudyIdInfo': {'id': '1308003'}, 'secondaryIdInfos': [{'id': '2013-A00094-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PROOF', 'description': 'Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)', 'interventionNames': ['Other: Dermatological clinical examination', 'Other: Biopsy', 'Other: Confocal microscopy in vivo']}], 'interventions': [{'name': 'Dermatological clinical examination', 'type': 'OTHER', 'description': 'Clinical pictures, Dermatoscopy, Elastography, Sebumetry', 'armGroupLabels': ['PROOF']}, {'name': 'Biopsy', 'type': 'OTHER', 'description': 'Skin biopsy for examinations by confocal microscopy ex vivo and histopathology', 'armGroupLabels': ['PROOF']}, {'name': 'Confocal microscopy in vivo', 'type': 'OTHER', 'description': 'Examination by confocal microscopy in vivo', 'armGroupLabels': ['PROOF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Elisa CINOTTI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}