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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05363904
Other study ID # 2021-01869
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source University of Zurich
Contact Danielle Fehr
Email tanzania.studie@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. This 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.


Description:

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): - Clinical characteristics, life quality, treatments, and family history - Immune mapping and barrier characterization of lesional and non-lesional skin - Exploration of the serological and cutaneous immune signatures - Investigation of the skin, nasal and gut microbiome (including bacteria and fungi) - Comparison of the sensitization patterns and putting it into clinical context (food questionnaire, anamnesis about allergic symptoms, analysis of IgE and IgG levels)


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: AD patients: - Age: =18 years - Written informed consent given after information about the research project - Suffering from active atopic dermatitis - No active skin disease other than atopic dermatitis - No known active inflammatory disease other than atopic dermatitis/atopic diseases HC participants: - Age: =18 years - Written informed consent given after information about the research project - No active skin disease - No known atopic disease (atopic dermatitis, asthma, allergy, allergic rhinoconjuncitivitis) - No known active inflammatory disease Exclusion Criteria: - Known or suspected systemic immunosuppression because of disease - Systemic immunomodulatory/-suppressive treatment - Glucocorticoids or immunosuppressants (last 4 weeks) or - JAK inhibitors (last week) or - Omalizumab (last 4 weeks) or - Other biologicals e.g. dupilumab (last 2 months) - Clinical signs of active bacterial, fungal or viral infection - Systemic antibiotic, antimycotic or antiviral treatment 4 weeks prior to start - Phototherapy 4 weeks prior to start - Active neoplasia - Undergoing surgery in the last 2 months - Infarction (e.g. stroke), embolism, or thrombosis in the last 2 months - Inability to follow the study procedures e.g. due to language problems, dementia etc. of the participant

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation
Questionnaires, Clinical Scores, Biomaterial Sampling

Locations

Country Name City State
Madagascar University Hospital Joseph Raseta Befelatanana Antananarivo
Switzerland University Hospital Zurich Zürich
Tanzania Regional Dermatology Training Centre (RDTC) Moshi

Sponsors (3)

Lead Sponsor Collaborator
University of Zurich Regional Dermatology Training Centre (RDTC), Moshi, Tanzania, University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar

Countries where clinical trial is conducted

Madagascar,  Switzerland,  Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total and specific IgE and IgG levels Will be put into clinical context with a questionnaire about food intake and allergic symptoms Day 0
Primary Questionnaire about food intake Information about how often the participants are consuming certain foods Day 0
Primary Questionnaire about the presence of allergic symptoms Information about symptoms upon allergen exposure Day 0
Primary Description of clinical appearance of AD on black vs. white skin Appearance, severity and distribution of the skin lesions Day 0
Primary Stigmata of atopic constitution The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form Day 0
Primary Skin microbiome (microbial colonization of the skin) Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site
Analysis by isolation and sequencing of the microbial DNA
Day 0
Primary Change of the skin microbiome components over time Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site
Analysis by isolation and sequencing of the microbial DNA
Day 0 and day 28
Primary Nasal microbiome (microbial colonization of the nasal vestibule) A nasal swab will be taken upon day 0
It will be used to grow cultures and analyse the microbial DNA
Day 0
Primary Gut microbiome (microbial colonization of the gut) Analysis by isolation and sequencing of the microbial DNA Day 0
Primary Cutaneous immune response Skin biopsies are optional and will be taken from lesional and non-lesional skin
They will be analyzed by imaging mass cytometry and spatial gene expression analysis
Day 0
Primary Systemic immune response Olink multiplex proteomics analyses and characterization of PBMCs will be performed Day 0
Primary Change of molecular and cellular mediators of the systemic immune response over time Olink multiplex proteomics analyses and characterization of PBMCs will be performed Day 0 and day 28
Primary Barrier dysfunction of the skin (Imaging Mass Cytometry) Skin biopsies are optional and will be taken from lesional and non-lesional skin Day 0
Primary Barrier dysfunction of the skin (Spatial gene expression analysis) Skin biopsies are optional and will be taken from lesional and non-lesional skin Day 0
Primary Family history of atopic diseases - Assessment of whether parents, siblings or other family members suffer from atopic diseases Day 0
Primary Questionnaire about current treatments Participants will be asked about their intake of medication and their use of topical treatments Day 0
Primary Life Quality measured by Dermatology Life Quality Index (DLQI) Min. 0, max. 30 points
Higher scores indicate a lower quality of life
Day 0
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