Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06313333
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2023-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Register of Moderate and Severe Adult Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiological data', 'timeFrame': 'from baseline through study completion, an average of 3 year', 'description': 'Reassessment of the epidemiology of AD'}, {'measure': 'Identification of factors for specific treatment', 'timeFrame': 'from baseline through study completion, an average of 3 year', 'description': 'Assessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD'}, {'measure': 'clinical and therapeutic data', 'timeFrame': 'from baseline through study completion, an average of 3 year', 'description': 'Assessment of any comorbidities;'}, {'measure': 'characterization of diagnostic criteria', 'timeFrame': 'from baseline through study completion, an average of 3 year', 'description': 'Outlining possible diagnostic criteria specific to AD in adults;'}, {'measure': 'Assessment of possible conditioning factors', 'timeFrame': 'from baseline through study completion, an average of 3 year', 'description': 'Evaluation of the natural history of AD and identification of possible conditioning factors;'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Collect clinical history and treatment data of AD in adulthood;', 'detailedDescription': 'Atopic dermatitis is a chronic-recurrent inflammatory skin disease with high prevalence in children and frequently presenting clinical remission during or after childhood; however, it may persist and/or recur, even after long and transient remission, adulthood. In addition, in some adult patients, DA is not present in pediatric age, but onset in adulthood: the investigators speak, in these cases, of adult-onset DA. The prevalence of DA is increasing all over the world and the cases in which clinical manifestations appear or persist during adolescence and/or adulthood are increased especially in industrialized countries. are not currently available specific laboratory markers for diagnosis of DA and, therefore, diagnosis is eminently clinical. In fact, at the present time, there are no validated diagnostic criteria, nor is there a clear consensus on diagnostic-therapeutic pathway to be followed when evaluating patients with adult DA. For these reasons, the collection of data related to various aspects of the DA such as those epidemiological, medical and clinical history, as well as the impact of the disease on the quality of life, results of crucial importance for estimating the real prevalence of this disease in Italy and also, possibly, to outline possible diagnostic criteria specific to adult DA, so that to facilitate and improve the diagnostic-therapeutic path of the patient. The intention of the project, therefore, is to create and use a National Register dedicated to DA patients in adulthood regardless of the period of onset of their pathology. aim to place the Italian Register as a supranational reference for international studies conducted on the adult DA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The nature of the study is descriptive. Each centre undertakes to recruit all adult patients diagnosed with moderate-severe atopic dermatitis observed at the center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years\n2. Signature of informed consent\n3. Diagnosis of moderate and/or severe DA by a dermatologist specialist defined on the basis of following criteria (10):\n\n * EASI 16\n * EASI \\<16 but with at least one of the following conditions:\n\n 1. location in at least one of the following "critical" locations: face, hands, genitals\n 2. QID \\> 10\n 3. VAS itching \\> 7\n 4. VAS sleep \\> 7\n\nExclusion Criteria:\n\n1. Patient unable to provide informed consent prior to any collection procedures data on the study;\n2. unable to complete the procedures required for the study;\n3. a patient already participating in another follow-up register of the same disease.'}, 'identificationModule': {'nctId': 'NCT06313333', 'acronym': 'ATOPYREG', 'briefTitle': 'National Register of Moderate and Severe Adult Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse'}, 'officialTitle': "Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto", 'orgStudyIdInfo': {'id': 'SID01'}}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piergiacomo MD Calzavara Pinton', 'role': 'CONTACT', 'email': 'piergiacomo.calzavarapinton@unibs.it', 'phone': '0303995305'}], 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'centralContacts': [{'name': 'Piergiacomo MD Calzavara Pinton', 'role': 'CONTACT', 'email': 'piergiacomo.calzavarapinton@unibs.it', 'phone': '0303995305'}], 'overallOfficials': [{'name': 'Piergiacomo MD Calzavara Pinton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST Spedali Civili di Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}