Atopic DermatitisNCT05363904
Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe
An observational study of Atopic Dermatitis, run by University of Zurich at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Observation
- How many people
- 240 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Mar 2022to 12 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with active atopic dermatitis and healthy control participants
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Madagascar1 site
University Hospital Joseph Raseta Befelatanana
Antananarivo
About this study
Official title: 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.
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)
- Conditions
- Atopic Dermatitis
- Being tested
- Observation
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Questionnaires, Clinical Scores, Biomaterial Sampling
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis (Europe) | Not described Receives: Other: Observation | |
| Healthy Controls (Europe) | Not described Receives: Other: Observation | |
| Atopic Dermatitis (Tanzania) | Not described Receives: Other: Observation | |
| Healthy Controls (Tanzania) | Not described Receives: Other: Observation | |
| Atopic Dermatitis (Madagascar) | Not described Receives: Other: Observation | |
| Healthy Controls (Madagascar) | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and specific IgE and IgG levels
Will be put into clinical context with a questionnaire about food intake and allergic symptoms
Measured: Day 0
Questionnaire about food intake
Information about how often the participants are consuming certain foods
Measured: Day 0
Questionnaire about the presence of allergic symptoms
Information about symptoms upon allergen exposure
Measured: Day 0
Description of clinical appearance of AD on black vs. white skin
Appearance, severity and distribution of the skin lesions
Measured: Day 0
Stigmata of atopic constitution
The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0
Gut microbiome (microbial colonization of the gut)
Analysis by isolation and sequencing of the microbial DNA
Measured: 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
Measured: Day 0
Systemic immune response
Olink multiplex proteomics analyses and characterization of PBMCs will be performed
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0
Family history of atopic diseases
- Assessment of whether parents, siblings or other family members suffer from atopic diseases
Measured: Day 0
Questionnaire about current treatments
Participants will be asked about their intake of medication and their use of topical treatments
Measured: Day 0
Life Quality measured by Dermatology Life Quality Index (DLQI)
- Min. 0, max. 30 points
- Higher scores indicate a lower quality of life
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start30 Mar 2022
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Dermatology Training Centre (RDTC), Moshi, Tanzania, University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar
- Responsible party
- Principal investigator, Marie-Charlotte Brüggen, University of Zurich
- Investigators
- Marie-Charlotte Brüggen, Prof., Principal investigator, University of ZurichDaudi Mavura, Prof., Principal investigator, RDTC MoshiJohn Masenga, Prof., Principal investigator, RDTC MoshiFandresena Sendrasoa, Dr., Principal investigator, University Hospital Joseph Raseta Befelatanana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363904
- Sponsor's protocol ID
- 2021-01869
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Impact and Immune Responses in Atopic Dermatitis Patients in Central Europe and Sub-Saharan Africa: A Prospective Study
- ClinicalTrials.gov ID
- NCT05363904
- Acronym / sponsor ID
- 2021-01869
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Regional Dermatology Training Centre (RDTC), Moshi, Tanzania, University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active atopic dermatitis and healthy control participants
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- Known or suspected systemic immunosuppression because of disease
- Systemic immunomodulatory/-suppressive treatment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationQuestionnaires, Clinical Scores, Biomaterial Sampling | Other | Atopic Dermatitis (Europe), Atopic Dermatitis (Madagascar), Atopic Dermatitis (Tanzania), Healthy Controls (Europe), Healthy Controls (Madagascar), Healthy Controls (Tanzania) |
Primary outcome
Total and specific IgE and IgG levels
Time frame: Day 0
Will be put into clinical context with a questionnaire about food intake and allergic symptoms
Questionnaire about food intake
Time frame: Day 0
Information about how often the participants are consuming certain foods
Questionnaire about the presence of allergic symptoms
Time frame: Day 0
Information about symptoms upon allergen exposure
Description of clinical appearance of AD on black vs. white skin
Time frame: Day 0
Appearance, severity and distribution of the skin lesions
Stigmata of atopic constitution
Time frame: Day 0
The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form
Skin microbiome (microbial colonization of the skin)
Time frame: Day 0
* 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
Change of the skin microbiome components over time
Time frame: Day 0 and day 28
* 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
Nasal microbiome (microbial colonization of the nasal vestibule)
Time frame: Day 0
* A nasal swab will be taken upon day 0 * It will be used to grow cultures and analyse the microbial DNA
Gut microbiome (microbial colonization of the gut)
Time frame: Day 0
Analysis by isolation and sequencing of the microbial DNA
Cutaneous immune response
Time frame: Day 0
* 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
Systemic immune response
Time frame: Day 0
Olink multiplex proteomics analyses and characterization of PBMCs will be performed
Change of molecular and cellular mediators of the systemic immune response over time
Time frame: Day 0 and day 28
Olink multiplex proteomics analyses and characterization of PBMCs will be performed
Barrier dysfunction of the skin (Imaging Mass Cytometry)
Time frame: Day 0
Skin biopsies are optional and will be taken from lesional and non-lesional skin
Barrier dysfunction of the skin (Spatial gene expression analysis)
Time frame: Day 0
Skin biopsies are optional and will be taken from lesional and non-lesional skin
Family history of atopic diseases
Time frame: Day 0
- Assessment of whether parents, siblings or other family members suffer from atopic diseases
Questionnaire about current treatments
Time frame: Day 0
Participants will be asked about their intake of medication and their use of topical treatments
Life Quality measured by Dermatology Life Quality Index (DLQI)
Time frame: Day 0
* Min. 0, max. 30 points * Higher scores indicate a lower quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 36468335Fehr 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.
- Flyer (University Hospital Zurich)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Charlotte Brüggen, Prof. principal investigator
University of Zurich
Daudi Mavura, Prof. principal investigator
RDTC Moshi
John Masenga, Prof. principal investigator
RDTC Moshi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by University of Zurich at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Madagascar, Switzerland, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and specific IgE and IgG levels (time frame: Day 0). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.