Comparing atopic dermatitis in Sub-Saharan Africa and Central Europe

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

This study looks at how atopic dermatitis affects people in Sub-Saharan Africa compared to those in Central Europe to see if there are differences in symptoms, treatments, and immune responses.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Zurich (Academic / other)
• Drugs / interventions: Omalizumab, dupilumab
• Locations: 3 sites (Antananarivo and 2 other locations)
• Trial ID: NCT05363904 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather clinical and laboratory data to compare the characteristics and immune responses of patients with atopic dermatitis (AD) in Sub-Saharan Africa and Central Europe. It will assess clinical features, quality of life, treatments, and family history, alongside immune mapping of skin lesions. Additionally, the study will explore the microbiomes of the skin, nasal passages, and gut, as well as sensitization patterns related to allergens. The goal is to enhance understanding of potential differences in AD pathogenesis across these regions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with active atopic dermatitis or healthy controls without any atopic diseases.

Not a fit: Patients with known systemic immunosuppression or those currently undergoing immunomodulatory treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of atopic dermatitis tailored to different populations.

How similar studies have performed: While studies on atopic dermatitis exist, this comparative approach focusing on different geographic populations is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Antananarivo and 2 other locations

• University Hospital Joseph Raseta Befelatanana — Antananarivo, Madagascar (Recruiting)
• University Hospital Zurich — Zürich, Switzerland (Completed)
• Regional Dermatology Training Centre (RDTC) — Moshi, Tanzania (Completed)

Study contacts

• Principal investigator: Marie-Charlotte Brüggen, Prof. — University of Zurich
• Study coordinator: Danielle Fehr

Conditions Atopic Dermatitis