Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT06103903
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measure of Acceptance of chRonic Visible sKin conditionS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D014820', 'term': 'Vitiligo'}, {'id': 'D019339', 'term': 'Port-Wine Stain'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire analysis', 'timeFrame': 'Up to 4 weeks', 'description': 'Analysis of responses to the 4 questionnaires (scales) evaluating the acceptance of chronic dermatological diseases visible in children, adolescents, adults and parents, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic dermatological disease', 'Psychology', 'Sociology', 'Disease Acceptance', 'Vitiligo', 'port wine stain', 'hyperpigmentation', 'alopecia areata'], 'conditions': ['Acceptance of Visible Chronic Dermatological Disease', 'Disease Acceptance', 'Psychological Well-Being', 'Social Segregation']}, 'descriptionModule': {'briefSummary': 'The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).', 'detailedDescription': 'The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).\n\nThe investigator will screen the patients and give them a link to complete the questionnaire (according to the age), that includes a pre-scale of acceptation of 50-55 items.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with visible chronic dermatological diseases and their family circle', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Targeted pathologies:\n\n * Flat angioma\n * Primary hypopigmentation and early vitiligo\n * Primary hyperpigmentation\n * Refractory alopecia areata or congenital alopecia\n2. Persons concerned:\n\n * Children (≥ 6 years old) suffering from one of the aforementioned pathologies\n * Adults suffering from one of the above-mentioned pathologies\n * Parents of children suffering from one of the aforementioned pathologies\n * Parents of young adult patients if they live under the same roof\n3. Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)\n\nExclusion Criteria:\n\n1. Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)\n2. Major psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT06103903', 'acronym': 'MARKS', 'briefTitle': 'Measure of Acceptance of chRonic Visible sKin conditionS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': "Acceptance Des Maladies Chroniques Dermatologiques Visibles : Constitution d'échelles Pour le Patient et Son Cluster Familial", 'orgStudyIdInfo': {'id': 'MARKS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children aged 6-13 years', 'description': 'Children aged 6-13 years with a chronic skin visible disease', 'interventionNames': ['Behavioral: Questionnaire']}, {'label': 'Adolescents aged 14-17 years', 'description': 'Adolescents aged 14-17 years years with a chronic skin visible disease', 'interventionNames': ['Behavioral: Questionnaire']}, {'label': 'Adult patients', 'description': 'Adult patients aged 18 years and more with a chronic skin visible disease', 'interventionNames': ['Behavioral: Questionnaire']}, {'label': 'Parents of children aged 6 years and more', 'description': 'Parents of children aged 6 years and more with a chronic skin visible disease', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Questionnaire according to age (6-13;14-17); the parents for minors and adults', 'armGroupLabels': ['Adolescents aged 14-17 years', 'Adult patients', 'Children aged 6-13 years', 'Parents of children aged 6 years and more']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Annabel MARUANI, MD-PhD', 'role': 'CONTACT', 'email': 'annabel.maruani@univ-tours.fr', 'phone': '+33247479076'}], 'facility': 'University Hospital TOURS', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Annabel MARUANI, MD-PhD', 'role': 'CONTACT', 'email': 'annabel.maruani@univ-tours.fr', 'phone': '+33 (0)247479076'}], 'overallOfficials': [{'name': 'Annabel MARUANI, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of TOURS'}, {'name': 'Jean-Benoit HARDOUIN, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'INSERM UMR 1246 SPHERE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM UMR 1246 SPHERE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}