Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 5:40 PM
Study NCT ID:
NCT06924333
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-11
First Post:
2025-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Skin Microbiota in Skin Disease and Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Skin microbiota, skin specimens, blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin microbiota', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'Characterization of skin microbiota are assessed at skin of patients with eczema or skin disease.'}, {'measure': 'Skin Barrier impairment tewl', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'meassurment of trans epidermal water loss (g/m2h)'}, {'measure': 'EASI', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'Eczema area and severity index are assessed (score 0-72)'}, {'measure': 'Patient oriented outcome measures RECAP', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'Recap of atopic eczema, RECAP. RECAP is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities.'}, {'measure': 'Patient oriented outcome measures POEM', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient.'}, {'measure': 'Patient oriented outcome measures DLQI', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease.'}, {'measure': 'Patient oriented outcome measures NRS Itch', 'timeFrame': 'At baseline/enrollment through study completion, an average of 1 year.', 'description': 'The Peak Pruritus Numerical Rating Scale (NRS) is a well-defined, reliable, fit-for-purpose measure to evaluate patient-reported intensity of worst itch in the previous 24 h for adults with moderate-to-severe atopic dermatitis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Disease', 'Eczema', 'Eczema Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Background: The skin microbiota influence skin health in several skin diseases and atopic dermatitis (AD). Presence of Staphylococcus have been associated to a sever course of the disease.\n\nObjectives: The aim of the study is to investigate the influence of bacteria, and the skin microbiota on the inflammation and skin barrier. Moreover, dysbiosis in the microbiota, the inflammation profile, the skin barrier damage will be related to objective and patient oriented measures.\n\nImportance: Knowledge of interactions between host defense, skin barrier and bacterial colonizing skin can facilitate development of new prevention and treatment strategies to control microbial impact in skin diseases and eczema.', 'detailedDescription': 'The role of the skin microbiome in atopic eczema and other skin diseases remains to be investigated. There are reports indicating an association of skin-colonization of Staphylococcus aureus (S. aureus) and the severity of the disease. Skin colonizing pathogens might be important cofactor for persistence of eczema and other skin diseases, as well as the commensal, non-pathogenic, microflora of the skin might have protective effects. The aim of this research project is to investigate the skin microbiome in patients with eczema and other skin diseases and elucidate the relation to skin barrier impairment and severity of the skin disease.\n\nSpecifically, we will:\n\n* Determine the skin microbiome and metagenome in skin of patients with eczema and other skin diseases.\n* Straighten out the relationship between the skin microbiome, the skin barrier, contact allergies, quality of life, eczema control and severity in patients with eczema and other skin diseases.\n* Identify biological markers, such as antimicrobial peptides, cytokines and gene-expression profiles in skin, and other factors contributing to the development and persistence of eczema and other skin diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patints with skin diseases, atopic eczema and eczema. Healthy volonteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Skin diseas, atopic eczema, eczema\n\n\\-\n\nExclusion Criteria:\n\n* Inabillity to give informed concent'}, 'identificationModule': {'nctId': 'NCT06924333', 'briefTitle': 'The Skin Microbiota in Skin Disease and Eczema', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'The Skin Microbiota in Skin Disease and Eczema', 'orgStudyIdInfo': {'id': '2024-06196-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with atopic eczema, eczema or other skin diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}