Clinical trial NCT05363904: Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe
Official title: Environmental Impact and Immune Responses in Atopic Dermatitis Patients in Central Europe and Sub-Saharan Africa: A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Regional Dermatology Training Centre (RDTC), Moshi, Tanzania
name: University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar
First posted: 2022-05-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active atopic dermatitis and healthy control participants

Brief 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.

Detailed 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)

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

Primary outcomes:
measure: Total and specific IgE and IgG levels
timeFrame: Day 0
measure: Questionnaire about food intake
timeFrame: Day 0
measure: Questionnaire about the presence of allergic symptoms
timeFrame: Day 0
measure: Description of clinical appearance of AD on black vs. white skin
timeFrame: Day 0
measure: Stigmata of atopic constitution
timeFrame: Day 0
measure: Skin microbiome (microbial colonization of the skin)
timeFrame: Day 0
measure: Change of the skin microbiome components over time
timeFrame: Day 0 and day 28
measure: Nasal microbiome (microbial colonization of the nasal vestibule)
timeFrame: Day 0
measure: Gut microbiome (microbial colonization of the gut)
timeFrame: Day 0
measure: Cutaneous immune response
timeFrame: Day 0
measure: Systemic immune response
timeFrame: Day 0
measure: Change of molecular and cellular mediators of the systemic immune response over time
timeFrame: Day 0 and day 28
measure: Barrier dysfunction of the skin (Imaging Mass Cytometry)
timeFrame: Day 0
measure: Barrier dysfunction of the skin (Spatial gene expression analysis)
timeFrame: Day 0
measure: Family history of atopic diseases
timeFrame: Day 0
measure: Questionnaire about current treatments
timeFrame: Day 0
measure: Life Quality measured by Dermatology Life Quality Index (DLQI)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Antananarivo
country: Madagascar
facility: University Hospital Joseph Raseta Befelatanana
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: Moshi
country: Tanzania
facility: Regional Dermatology Training Centre (RDTC)
Study officials:
affiliation: University of Zurich
name: Marie-Charlotte Brüggen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: RDTC Moshi
name: Daudi Mavura, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: RDTC Moshi
name: John Masenga, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Joseph Raseta Befelatanana
name: Fandresena Sendrasoa, Dr.
role: PRINCIPAL_INVESTIGATOR
References: