Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

NCT ID: NCT05363904

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-30

Study Completion Date

2025-03-12

Brief Summary

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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

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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)

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Atopic Dermatitis (Europe)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Healthy Controls (Europe)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Atopic Dermatitis (Tanzania)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Healthy Controls (Tanzania)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Atopic Dermatitis (Madagascar)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Healthy Controls (Madagascar)

Observation

Intervention Type OTHER

Questionnaires, Clinical Scores, Biomaterial Sampling

Interventions

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Observation

Questionnaires, Clinical Scores, Biomaterial Sampling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Dermatology Training Centre (RDTC), Moshi, Tanzania

UNKNOWN

Sponsor Role collaborator

University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Marie-Charlotte Brüggen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-Charlotte Brüggen, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Daudi Mavura, Prof.

Role: PRINCIPAL_INVESTIGATOR

RDTC Moshi

John Masenga, Prof.

Role: PRINCIPAL_INVESTIGATOR

RDTC Moshi

Fandresena Sendrasoa, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Joseph Raseta Befelatanana

Locations

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University Hospital Joseph Raseta Befelatanana

Antananarivo, , Madagascar

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Regional Dermatology Training Centre (RDTC)

Moshi, , Tanzania

Site Status

Countries

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Madagascar Switzerland Tanzania

References

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Fehr D, Lang C, Masenga J, Mavura D, Schmid-Grendelmeier P, Bruggen MC. Atopic dermatitis: The importance of future research in Africa. Allergy. 2023 Jan;78(1):327-328. doi: 10.1111/all.15422. Epub 2022 Dec 5. No abstract available.

Reference Type DERIVED
PMID: 36468335 (View on PubMed)

Related Links

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Other Identifiers

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2021-01869

Identifier Type: -

Identifier Source: org_study_id

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