Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

University of Zurich240 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Atopic Dermatitis

Interventions

ObservationOTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

University Hospital Joseph Raseta Befelatanana

Antananarivo, Madagascar

University Hospital Zurich

Zurich, Switzerland

Regional Dermatology Training Centre (RDTC)

Moshi, Tanzania

Outcomes

Primary Outcomes

Total and specific IgE and IgG levels

Will be put into clinical context with a questionnaire about food intake and allergic symptoms

Time frame: Day 0

Questionnaire about food intake

Information about how often the participants are consuming certain foods

Time frame: Day 0

Questionnaire about the presence of allergic symptoms

Information about symptoms upon allergen exposure

Time frame: Day 0

Description of clinical appearance of AD on black vs. white skin

Appearance, severity and distribution of the skin lesions

Time frame: Day 0

Stigmata of atopic constitution

The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form

Time frame: Day 0

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

Time frame: Day 0

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

Time frame: Day 0 and day 28

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

Data from ClinicalTrials.gov

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