Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT05078294
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results in Real Clinical Practice of Treatment of Moderate-severe 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-30', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who showed a change in disease severity.', 'timeFrame': 'Up to 30 weeks', 'description': 'Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological.'}], 'secondaryOutcomes': [{'measure': 'Medication-related adverse effect rate.', 'timeFrame': 'Up to 30 weeks', 'description': 'Number of adverse effects.'}, {'measure': 'Evaluation of quality of life parameters.', 'timeFrame': 'Up to 30 weeks', 'description': 'Completion of the self-administered dermatology quality of life index questionnaire, which measures the quality of life of the patient.\n\nNumerical variable (range 0-30) obtained from a self-administered questionnaire already validated in Spanish, which measures the quality of life of surveyed, consisting of 10 questions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.', 'detailedDescription': "This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.\n\nParticipants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).\n\nA series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years.\n* Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab.\n* Patients who grant informed consent.\n\nExclusion Criteria:\n\n* Patients who do not have the necessary comprehension capacity to understand and sign the informed consent.\n* Patients who, according to routine clinical practice, require only topical treatment.'}, 'identificationModule': {'nctId': 'NCT05078294', 'acronym': 'Dermatitis', 'briefTitle': 'Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Results in Real Clinical Practice of Treatment With Patients With Moderate-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'FIS-DER-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients treated as monotherapy with phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib, or tralokilumab for the treatment of moderate to severe atopic dermatitis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08402', 'city': 'Granollers', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Guilabert Vidal', 'role': 'CONTACT', 'phone': '938 42 50 00'}, {'name': 'Antonio Guilabert Vidal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'zip': '11510', 'city': 'Puerto Real', 'state': 'Cádiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Carlos Armario Hita', 'role': 'CONTACT', 'phone': '956 00 50 00'}, {'name': 'José Carlos Armario Hita', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Puerta Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Elosua González', 'role': 'CONTACT', 'phone': '911 91 60 00'}, {'name': 'Ángel Rosell Díaz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gaston Roustan Gullón', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '03010', 'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Francisco Silvestre Salvador', 'role': 'CONTACT', 'phone': '965 93 30 00'}, {'name': 'Juan Francisco Silvestre Salvador', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esther Serra-Baldrich', 'role': 'CONTACT', 'phone': '93 291 90 00'}, {'name': 'Esther Serra-Baldrich', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Victor Flores', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guillermo Sánchez', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Juan Pereyra Rodríguez', 'role': 'CONTACT', 'email': 'josej.pereyra.sspa@juntadeandalucia.es', 'phone': '955 01 20 00'}, {'name': 'José Juan Pereyra Rodríguez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46015', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Javier Miquel Miquel', 'role': 'CONTACT', 'phone': '961 97 60 00'}, {'name': 'Francisco Javier Miquel Miquel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'José Juan Pereyra Rodríguez', 'role': 'CONTACT', 'email': 'josej.pereyra.sspa@juntadeandalucia.es', 'phone': '955 01 20 00'}, {'name': 'Carlos García Pérez', 'role': 'CONTACT', 'email': 'administracion.eecc.hvm.sspa@juntadeandalucia.es', 'phone': '955 04 31 27'}], 'overallOfficials': [{'name': 'José Juan Pereyra Rodríguez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}