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Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: Observation

Study type

Observational

Funder types

Other

Identifiers

NCT05363904
2021-01869

Details and patient eligibility

About

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.

Full 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)

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

240 participants in 6 patient groups

Atopic Dermatitis (Europe)
Treatment:
Other: Observation
Healthy Controls (Europe)
Treatment:
Other: Observation
Atopic Dermatitis (Tanzania)
Treatment:
Other: Observation
Healthy Controls (Tanzania)
Treatment:
Other: Observation
Atopic Dermatitis (Madagascar)
Treatment:
Other: Observation
Healthy Controls (Madagascar)
Treatment:
Other: Observation

Trial contacts and locations

3

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Central trial contact

Danielle Fehr

Data sourced from clinicaltrials.gov

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