Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Observation

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)

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Danielle Fehr; Email: tanzania.studie@usz.ch

Study Locations

• Madagascar
  • Antananarivo, Madagascar
    • Recruiting
    • University Hospital Joseph Raseta Befelatanana
    • Contact: Fandresena Sendrasoa, Dr.
    • Contact: Fahafahantsoa Rapelanoro Rabenja, Prof.
• Switzerland
  • Zürich, Switzerland
    • Completed
    • University Hospital Zurich
• Tanzania
  • Moshi, Tanzania
    • Completed
    • Regional Dermatology Training Centre (RDTC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with active atopic dermatitis and healthy control participants

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic Dermatitis (Europe)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling
Healthy Controls (Europe)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling
Atopic Dermatitis (Tanzania)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling
Healthy Controls (Tanzania)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling
Atopic Dermatitis (Madagascar)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling
Healthy Controls (Madagascar)	Other: Observation; Questionnaires, Clinical Scores, Biomaterial Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total and specific IgE and IgG levels	Will be put into clinical context with a questionnaire about food intake and allergic symptoms	Day 0
Questionnaire about food intake	Information about how often the participants are consuming certain foods	Day 0
Questionnaire about the presence of allergic symptoms	Information about symptoms upon allergen exposure	Day 0
Description of clinical appearance of AD on black vs. white skin	Appearance, severity and distribution of the skin lesions	Day 0
Stigmata of atopic constitution	The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form	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	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	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	Day 0
Gut microbiome (microbial colonization of the gut)	Analysis by isolation and sequencing of the microbial DNA	Day 0
Cutaneous immune response	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	Day 0
Systemic immune response	Olink multiplex proteomics analyses and characterization of PBMCs will be performed	Day 0
Change of molecular and cellular mediators of the systemic immune response over time	Olink multiplex proteomics analyses and characterization of PBMCs will be performed	Day 0 and day 28
Barrier dysfunction of the skin (Imaging Mass Cytometry)	Skin biopsies are optional and will be taken from lesional and non-lesional skin	Day 0
Barrier dysfunction of the skin (Spatial gene expression analysis)	Skin biopsies are optional and will be taken from lesional and non-lesional skin	Day 0
Family history of atopic diseases	- Assessment of whether parents, siblings or other family members suffer from atopic diseases	Day 0
Questionnaire about current treatments	Participants will be asked about their intake of medication and their use of topical treatments	Day 0
Life Quality measured by Dermatology Life Quality Index (DLQI)	Min. 0, max. 30 points; Higher scores indicate a lower quality of life	Day 0

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Regional Dermatology Training Centre (RDTC), Moshi, Tanzania; University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar
• Investigators: Principal Investigator: Marie-Charlotte Brüggen, Prof., University of Zurich; Principal Investigator: Daudi Mavura, Prof., RDTC Moshi; Principal Investigator: John Masenga, Prof., RDTC Moshi; Principal Investigator: Fandresena Sendrasoa, Dr., University Hospital Joseph Raseta Befelatanana

Publications and helpful links

Helpful Links

• Flyer (University Hospital Zurich)

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 2021-01869

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No