Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-02 @ 12:01 AM
Study NCT ID:
NCT03271320
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual scale for aesthetic burden', 'timeFrame': 'Baseline', 'description': 'Visual scale for aesthetic burden from 0 to 10'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with Appearance Scale (SWAP)', 'timeFrame': 'Baseline', 'description': 'The SWAP measures body image dissatisfaction in persons with visible disfigurement'}, {'measure': 'Derriford Appearance Scale-59 (DAS)', 'timeFrame': 'Baseline', 'description': 'The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance.'}, {'measure': 'Multidimensional Body self Relations Questionnaire (MBSRQ)', 'timeFrame': 'Baseline', 'description': 'The Multidimensional Body-Self Relations Questionnaire (MBSRQ) is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the body-image construct.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '38910601', 'type': 'DERIVED', 'citation': 'Farhat MM, Guerreschi P, Morell-Dubois S, Deken V, Labreuche J, Sanges S, Sobanski V, Hachulla E, Cottencin O, Launay D. Perception of aesthetic impairment in patients with systemic sclerosis determined using a semi-quantitative scale and its association with disease characteristics. J Scleroderma Relat Disord. 2024 Jun;9(2):124-133. doi: 10.1177/23971983241231620. Epub 2024 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the burden of aesthetic complication in systemic sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the appearance. Aesthetic burden will be assessed through several scales and compared to a control group of health subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'systemic sclerosis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemic sclerosis according to ACR-EULAR 2013\n\nExclusion Criteria:\n\n* non French native\n* aesthetic sequel from other conditions'}, 'identificationModule': {'nctId': 'NCT03271320', 'acronym': 'SCLERO-ESTHET', 'briefTitle': 'Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis', 'orgStudyIdInfo': {'id': '2014_63'}, 'secondaryIdInfos': [{'id': '2016-A00735-46', 'type': 'OTHER', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'systemic sclerosis', 'description': 'patients with systemic sclerosis', 'interventionNames': ['Other: appearance scales']}, {'label': 'control', 'description': 'Healthy subjects', 'interventionNames': ['Other: appearance scales']}], 'interventions': [{'name': 'appearance scales', 'type': 'OTHER', 'description': 'appearance scales : AVS; ASWAP; DAS 59', 'armGroupLabels': ['control', 'systemic sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}