Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-05 @ 2:44 AM
Study NCT ID:
NCT05363904
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Blood samples\n* Skin biopsies\n* Skin swabs\n* Nasal swabs\n* Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total and specific IgE and IgG levels', 'timeFrame': 'Day 0', 'description': 'Will be put into clinical context with a questionnaire about food intake and allergic symptoms'}, {'measure': 'Questionnaire about food intake', 'timeFrame': 'Day 0', 'description': 'Information about how often the participants are consuming certain foods'}, {'measure': 'Questionnaire about the presence of allergic symptoms', 'timeFrame': 'Day 0', 'description': 'Information about symptoms upon allergen exposure'}, {'measure': 'Description of clinical appearance of AD on black vs. white skin', 'timeFrame': 'Day 0', 'description': 'Appearance, severity and distribution of the skin lesions'}, {'measure': 'Stigmata of atopic constitution', 'timeFrame': 'Day 0', 'description': 'The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form'}, {'measure': 'Skin microbiome (microbial colonization of the skin)', 'timeFrame': 'Day 0', 'description': '* Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site\n* Analysis by isolation and sequencing of the microbial DNA'}, {'measure': 'Change of the skin microbiome components over time', 'timeFrame': 'Day 0 and day 28', 'description': '* Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site\n* Analysis by isolation and sequencing of the microbial DNA'}, {'measure': 'Nasal microbiome (microbial colonization of the nasal vestibule)', 'timeFrame': 'Day 0', 'description': '* A nasal swab will be taken upon day 0\n* It will be used to grow cultures and analyse the microbial DNA'}, {'measure': 'Gut microbiome (microbial colonization of the gut)', 'timeFrame': 'Day 0', 'description': 'Analysis by isolation and sequencing of the microbial DNA'}, {'measure': 'Cutaneous immune response', 'timeFrame': 'Day 0', 'description': '* Skin biopsies are optional and will be taken from lesional and non-lesional skin\n* They will be analyzed by imaging mass cytometry and spatial gene expression analysis'}, {'measure': 'Systemic immune response', 'timeFrame': 'Day 0', 'description': 'Olink multiplex proteomics analyses and characterization of PBMCs will be performed'}, {'measure': 'Change of molecular and cellular mediators of the systemic immune response over time', 'timeFrame': 'Day 0 and day 28', 'description': 'Olink multiplex proteomics analyses and characterization of PBMCs will be performed'}, {'measure': 'Barrier dysfunction of the skin (Imaging Mass Cytometry)', 'timeFrame': 'Day 0', 'description': 'Skin biopsies are optional and will be taken from lesional and non-lesional skin'}, {'measure': 'Barrier dysfunction of the skin (Spatial gene expression analysis)', 'timeFrame': 'Day 0', 'description': 'Skin biopsies are optional and will be taken from lesional and non-lesional skin'}, {'measure': 'Family history of atopic diseases', 'timeFrame': 'Day 0', 'description': '\\- Assessment of whether parents, siblings or other family members suffer from atopic diseases'}, {'measure': 'Questionnaire about current treatments', 'timeFrame': 'Day 0', 'description': 'Participants will be asked about their intake of medication and their use of topical treatments'}, {'measure': 'Life Quality measured by Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Day 0', 'description': '* Min. 0, max. 30 points\n* Higher scores indicate a lower quality of life'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '36468335', 'type': 'DERIVED', 'citation': 'Fehr D, Lang C, Masenga J, Mavura D, Schmid-Grendelmeier P, Bruggen MC. Atopic dermatitis: The importance of future research in Africa. Allergy. 2023 Jan;78(1):327-328. doi: 10.1111/all.15422. Epub 2022 Dec 5. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.usz.ch/studie/neurodermitis-neurodermitis-in-europa-und-subsahara-afrika/', 'label': 'Flyer (University Hospital Zurich)'}]}, 'descriptionModule': {'briefSummary': 'Many people are affected by atopic dermatitis (AD) worldwide. However, clinical studies on AD in Sub-Saharan Africa are rare and there is a lack of knowledge about possible differences in pathogenesis between European and African AD.\n\nThis study will collect clinical and laboratory data with the aim to compare clinical characteristics and immune responses in AD patients in Sub-Saharan Africa and Central Europe. Furthermore, relevant allergens as well as the nasal, skin and gut micro- and mycobiome will be investigated.', 'detailedDescription': 'Objectives of the project: Compare the following aspects in patients suffering from atopic dermatitis (AD) and healthy control (HC) participants in Central Europe (CE) vs. Sub-Saharan Africa (SsA):\n\n* Clinical characteristics, life quality, treatments, and family history\n* Immune mapping and barrier characterization of lesional and non-lesional skin\n* Exploration of the serological and cutaneous immune signatures\n* Investigation of the skin, nasal and gut microbiome (including bacteria and fungi)\n* Comparison of the sensitization patterns and putting it into clinical context (food questionnaire, anamnesis about allergic symptoms, analysis of IgE and IgG levels)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with active atopic dermatitis and healthy control participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAD patients:\n\n* Age: ≥18 years\n* Written informed consent given after information about the research project\n* Suffering from active atopic dermatitis\n* No active skin disease other than atopic dermatitis\n* No known active inflammatory disease other than atopic dermatitis/atopic diseases\n\nHC participants:\n\n* Age: ≥18 years\n* Written informed consent given after information about the research project\n* No active skin disease\n* No known atopic disease (atopic dermatitis, asthma, allergy, allergic rhinoconjuncitivitis)\n* No known active inflammatory disease\n\nExclusion Criteria:\n\n* Known or suspected systemic immunosuppression because of disease\n* Systemic immunomodulatory/-suppressive treatment\n\n * Glucocorticoids or immunosuppressants (last 4 weeks) or\n * JAK inhibitors (last week) or\n * Omalizumab (last 4 weeks) or\n * Other biologicals e.g. dupilumab (last 2 months)\n* Clinical signs of active bacterial, fungal or viral infection\n* Systemic antibiotic, antimycotic or antiviral treatment 4 weeks prior to start\n* Phototherapy 4 weeks prior to start\n* Active neoplasia\n* Undergoing surgery in the last 2 months\n* Infarction (e.g. stroke), embolism, or thrombosis in the last 2 months\n* Inability to follow the study procedures e.g. due to language problems, dementia etc. of the participant'}, 'identificationModule': {'nctId': 'NCT05363904', 'briefTitle': 'Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Environmental Impact and Immune Responses in Atopic Dermatitis Patients in Central Europe and Sub-Saharan Africa: A Prospective Study', 'orgStudyIdInfo': {'id': '2021-01869'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atopic Dermatitis (Europe)', 'interventionNames': ['Other: Observation']}, {'label': 'Healthy Controls (Europe)', 'interventionNames': ['Other: Observation']}, {'label': 'Atopic Dermatitis (Tanzania)', 'interventionNames': ['Other: Observation']}, {'label': 'Healthy Controls (Tanzania)', 'interventionNames': ['Other: Observation']}, {'label': 'Atopic Dermatitis (Madagascar)', 'interventionNames': ['Other: Observation']}, {'label': 'Healthy Controls (Madagascar)', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Questionnaires, Clinical Scores, Biomaterial Sampling', 'armGroupLabels': ['Atopic Dermatitis (Europe)', 'Atopic Dermatitis (Madagascar)', 'Atopic Dermatitis (Tanzania)', 'Healthy Controls (Europe)', 'Healthy Controls (Madagascar)', 'Healthy Controls (Tanzania)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antananarivo', 'country': 'Madagascar', 'facility': 'University Hospital Joseph Raseta Befelatanana', 'geoPoint': {'lat': -18.91368, 'lon': 47.53613}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Moshi', 'country': 'Tanzania', 'facility': 'Regional Dermatology Training Centre (RDTC)', 'geoPoint': {'lat': -3.35, 'lon': 37.33333}}], 'overallOfficials': [{'name': 'Marie-Charlotte Brüggen, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}, {'name': 'Daudi Mavura, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RDTC Moshi'}, {'name': 'John Masenga, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RDTC Moshi'}, {'name': 'Fandresena Sendrasoa, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Joseph Raseta Befelatanana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional Dermatology Training Centre (RDTC), Moshi, Tanzania', 'class': 'UNKNOWN'}, {'name': 'University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marie-Charlotte Brüggen', 'investigatorAffiliation': 'University of Zurich'}}}}