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Completed

NCT Number: NCT05363904

Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Questionnaires, Clinical Scores, Biomaterial Sampling

Primary outcomes

  1. Total and specific IgE and IgG levels

    Time frame: Day 0

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

  2. Questionnaire about food intake

    Time frame: Day 0

    Information about how often the participants are consuming certain foods

  3. Questionnaire about the presence of allergic symptoms

    Time frame: Day 0

    Information about symptoms upon allergen exposure

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

    Time frame: Day 0

    Appearance, severity and distribution of the skin lesions

  5. Stigmata of atopic constitution

    Time frame: Day 0

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

  6. Skin microbiome (microbial colonization of the skin)

    Time frame: Day 0

    • 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

  7. Change of the skin microbiome components over time

    Time frame: Day 0 and day 28

    • 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

  8. Nasal microbiome (microbial colonization of the nasal vestibule)

    Time frame: Day 0

    • A nasal swab will be taken upon day 0
    • It will be used to grow cultures and analyse the microbial DNA

  9. Gut microbiome (microbial colonization of the gut)

    Time frame: Day 0

    Analysis by isolation and sequencing of the microbial DNA

  10. Cutaneous immune response

    Time frame: Day 0

    • 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

  11. Systemic immune response

    Time frame: Day 0

    Olink multiplex proteomics analyses and characterization of PBMCs will be performed

  12. Change of molecular and cellular mediators of the systemic immune response over time

    Time frame: Day 0 and day 28

    Olink multiplex proteomics analyses and characterization of PBMCs will be performed

  13. Barrier dysfunction of the skin (Imaging Mass Cytometry)

    Time frame: Day 0

    Skin biopsies are optional and will be taken from lesional and non-lesional skin

  14. Barrier dysfunction of the skin (Spatial gene expression analysis)

    Time frame: Day 0

    Skin biopsies are optional and will be taken from lesional and non-lesional skin

  15. Family history of atopic diseases

    Time frame: Day 0

    • Assessment of whether parents, siblings or other family members suffer from atopic diseases

  16. Questionnaire about current treatments

    Time frame: Day 0

    Participants will be asked about their intake of medication and their use of topical treatments

  17. Life Quality measured by Dermatology Life Quality Index (DLQI)

    Time frame: Day 0

    • Min. 0, max. 30 points
    • Higher scores indicate a lower quality of life

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Regional Dermatology Training Centre (RDTC), Moshi, Tanzania
  • University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar

Registry information

Official study title

Environmental Impact and Immune Responses in Atopic Dermatitis Patients in Central Europe and Sub-Saharan Africa: A Prospective Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 6, 2022
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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