Atopic Dermatitis: Sub-Saharan Africa vs. Central Europe

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363904
• Other study ID #: 2021-01869
• Status: Recruiting
• Start date: March 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Zurich
• Contact: Danielle Fehr
• Email: tanzania.studie[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Observation
Questionnaires, Clinical Scores, Biomaterial Sampling

Locations

Country	Name	City	State
Madagascar	University Hospital Joseph Raseta Befelatanana	Antananarivo
Switzerland	University Hospital Zurich	Zürich
Tanzania	Regional Dermatology Training Centre (RDTC)	Moshi

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Regional Dermatology Training Centre (RDTC), Moshi, Tanzania, University Hospital Joseph Raseta Befelatanana in Antananarivo, Madagascar

Countries where clinical trial is conducted

Madagascar,  Switzerland,  Tanzania, 

Outcome

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

External Links

•   Flyer (University Hospital Zurich)