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CompletedNCT05363904Updated Jul 9, 2025

Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

An observational study in Atopic Dermatitis, sponsored by University of Zurich. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 240 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with active atopic dermatitis and healthy control participants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

AD patients:

  • Age: ≥18 years
  • Written 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

Exclusion Criteria:

  • Known or suspected systemic because of disease
  • Systemic immunomodulatory/-suppressive treatment

    • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Atopic Dermatitis (Europe)

    Other: Observation

  • Healthy Controls (Europe)

    Other: Observation

  • Atopic Dermatitis (Tanzania)

    Other: Observation

  • Healthy Controls (Tanzania)

    Other: Observation

  • Atopic Dermatitis (Madagascar)

    Other: Observation

  • Healthy Controls (Madagascar)

    Other: Observation

Interventions

  • OtherObservation

    Questionnaires, Clinical Scores, Biomaterial Sampling

06

What researchers measure

Primary outcomes

  1. Total and specific IgE and IgG levels

    Will be put into clinical context with a questionnaire about food intake and allergic symptoms

    Time frame: Day 0

  2. Questionnaire about food intake

    Information about how often the participants are consuming certain foods

    Time frame: Day 0

  3. Questionnaire about the presence of allergic symptoms

    Information about symptoms upon allergen exposure

    Time frame: Day 0

  4. Description of clinical appearance of AD on black vs. white skin

    Appearance, severity and distribution of the skin lesions

    Time frame: Day 0

  5. Stigmata of atopic constitution

    The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form

    Time frame: Day 0

  6. 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

    Time frame: Day 0

  7. 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

    Time frame: Day 0 and day 28

  8. 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

    Time frame: Day 0

  9. Gut microbiome (microbial colonization of the gut)

    Analysis by isolation and sequencing of the microbial DNA

    Time frame: Day 0

  10. 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

    Time frame: Day 0

  11. Systemic immune response

    Olink multiplex proteomics analyses and characterization of PBMCs will be performed

    Time frame: Day 0

  12. Change of molecular and cellular mediators of the systemic immune response over time

    Olink multiplex proteomics analyses and characterization of PBMCs will be performed

    Time frame: Day 0 and day 28

  13. Barrier dysfunction of the skin (Imaging Mass Cytometry)

    Skin biopsies are optional and will be taken from lesional and non-lesional skin

    Time frame: Day 0

  14. Barrier dysfunction of the skin (Spatial gene expression analysis)

    Skin biopsies are optional and will be taken from lesional and non-lesional skin

    Time frame: Day 0

  15. Family history of atopic diseases

    \- Assessment of whether parents, siblings or other family members suffer from atopic diseases

    Time frame: Day 0

  16. Questionnaire about current treatments

    Participants will be asked about their intake of medication and their use of topical treatments

    Time frame: Day 0

  17. Life Quality measured by Dermatology Life Quality Index (DLQI)

    * Min. 0, max. 30 points * Higher scores indicate a lower quality of life

    Time frame: Day 0

07

Study locations

3 sites
  • University Hospital Joseph Raseta Befelatanana
    Antananarivo, Madagascar
  • University Hospital Zurich
    Zurich, Switzerland
  • Regional Dermatology Training Centre (RDTC)
    Moshi, Tanzania
08

References and documents

Publications

  • 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. PubMed 36468335 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Mar 2025, 35 months.

Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's 35 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2022
First posted
May 6, 2022
StartActual
Mar 30, 2022
Primary completionActual
Mar 12, 2025
CompletionActual
Mar 12, 2025
Last update
Jul 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05363904
Collaborators
Regional Dermatology Training Centre (RDTC), Moshi, Tanzania, University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar
Responsible party
Marie-Charlotte Brüggen (Principal Investigator, University of Zurich) — Principal investigator
First posted
May 6, 2022
Start date
Mar 30, 2022
Primary completion
Mar 12, 2025
Completion
Mar 12, 2025
Last update
Jul 9, 2025

Study contacts

Marie-Charlotte Brüggen, Prof.
principal investigator · University of Zurich
Daudi Mavura, Prof.
principal investigator · RDTC Moshi
John Masenga, Prof.
principal investigator · RDTC Moshi
Fandresena Sendrasoa, Dr.
principal investigator · University Hospital Joseph Raseta Befelatanana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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