Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-29 @ 12:10 PM
Study NCT ID:
NCT03872050
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Phenotyping of Rosacea and Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mouthswab for DNA-sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of migraine in rosacea cohort', 'timeFrame': '60 minutes', 'description': 'Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine'}, {'measure': 'Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort', 'timeFrame': '60 minutes', 'description': 'Prevalence of patients in migraine cohort who fulfill diagnostic criteria for rosacea'}], 'secondaryOutcomes': [{'measure': 'Prevalence of migraine subtypes in rosacea cohort', 'timeFrame': '60 minutes', 'description': 'Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for subtypes of migraine according to international headache society classification'}, {'measure': 'Prevalence of rosacea subtypes in migraine cohort', 'timeFrame': '60 minutes', 'description': 'Prevalence of patients in migraine cohort who fulfill diagnostic criteria for subtypes of rosacea'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine', 'Rosacea']}, 'referencesModule': {'references': [{'pmid': '38558478', 'type': 'DERIVED', 'citation': 'Wienholtz NKF, Christensen CE, Ashina H, Jorgensen NR, Egeberg A, Thyssen JP, Ashina M. Elevated plasma levels of calcitonin gene-related peptide in individuals with rosacea: A cross-sectional case-control study. J Eur Acad Dermatol Venereol. 2025 Jan;39(1):181-188. doi: 10.1111/jdv.19954. Epub 2024 Apr 1.'}, {'pmid': '32819957', 'type': 'DERIVED', 'citation': 'Wienholtz NKF, Christensen CE, Haugaard JH, Zhang DG, Ashina M, Thyssen JP, Egeberg A. Cohort profile: COpenhagen ROsacea COhort (COROCO) and COpenhagen MIgraine COhort (COMICO). BMJ Open. 2020 Aug 20;10(8):e039445. doi: 10.1136/bmjopen-2020-039445.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to deep phenotype patients with rosacea and migraine', 'detailedDescription': 'Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated.\n\nThe purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rosacea\n\n* patients invited to participate through 3 different clinics in Copenhagen and Zealand, Denmark\n\nMigraine\n\n* patients attending the outpatient clinic of the Danish Headache Center invited to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis with either rosacea and/or migraine\n\nExclusion Criteria:\n\n* does not want to participate\n* cannot co-operate to investigation'}, 'identificationModule': {'nctId': 'NCT03872050', 'briefTitle': 'Deep Phenotyping of Rosacea and Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Deep Phenotyping of Rosacea and Migraine', 'orgStudyIdInfo': {'id': 'RosMigInterview'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rosacea', 'description': 'Patients who have been diagnosed with rosacea', 'interventionNames': ['Diagnostic Test: No intervention apart from tests, including interview']}, {'label': 'Migraine', 'description': 'Patients who have been diagnosed with migraine', 'interventionNames': ['Diagnostic Test: No intervention apart from tests, including interview']}], 'interventions': [{'name': 'No intervention apart from tests, including interview', 'type': 'DIAGNOSTIC_TEST', 'description': 'No interventions', 'armGroupLabels': ['Migraine', 'Rosacea']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.84354, 'lon': 11.66675}}], 'overallOfficials': [{'name': 'Messoud Ashina, MD, PhD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor, PhD Fellow', 'investigatorFullName': 'Nita Katarina Frifelt Wienholtz', 'investigatorAffiliation': 'Danish Headache Center'}}}}