Clinical trial NCT06924333: The Skin Microbiota in Skin Disease and Eczema
Official title: The Skin Microbiota in Skin Disease and Eczema
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Skin Disease
Eczema
Eczema Atopic Dermatitis
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patints with skin diseases, atopic eczema and eczema. Healthy volonteers.

Brief summary: Background: The skin microbiota influence skin health in several skin diseases and atopic dermatitis (AD). Presence of Staphylococcus have been associated to a sever course of the disease.

Objectives: The aim of the study is to investigate the influence of bacteria, and the skin microbiota on the inflammation and skin barrier. Moreover, dysbiosis in the microbiota, the inflammation profile, the skin barrier damage will be related to objective and patient oriented measures.

Importance: Knowledge of interactions between host defense, skin barrier and bacterial colonizing skin can facilitate development of new prevention and treatment strategies to control microbial impact in skin diseases and eczema.

Detailed description: The role of the skin microbiome in atopic eczema and other skin diseases remains to be investigated. There are reports indicating an association of skin-colonization of Staphylococcus aureus (S. aureus) and the severity of the disease. Skin colonizing pathogens might be important cofactor for persistence of eczema and other skin diseases, as well as the commensal, non-pathogenic, microflora of the skin might have protective effects. The aim of this research project is to investigate the skin microbiome in patients with eczema and other skin diseases and elucidate the relation to skin barrier impairment and severity of the skin disease.

Specifically, we will:

* Determine the skin microbiome and metagenome in skin of patients with eczema and other skin diseases.
* Straighten out the relationship between the skin microbiome, the skin barrier, contact allergies, quality of life, eczema control and severity in patients with eczema and other skin diseases.
* Identify biological markers, such as antimicrobial peptides, cytokines and gene-expression profiles in skin, and other factors contributing to the development and persistence of eczema and other skin diseases.

Eligibility criteria: Inclusion Criteria: Skin diseas, atopic eczema, eczema

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Exclusion Criteria:

* Inabillity to give informed concent

Primary outcomes:
measure: Skin microbiota
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: Skin Barrier impairment tewl
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: EASI
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: Patient oriented outcome measures RECAP
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: Patient oriented outcome measures POEM
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: Patient oriented outcome measures DLQI
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
measure: Patient oriented outcome measures NRS Itch
timeFrame: At baseline/enrollment through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
state: Skane
Study officials:
References: