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Enrolling by Invitation

NCT Number: NCT06924333

The Skin Microbiota in Skin Disease and Eczema

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.

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Key information

Conditions

Skin Disease Dermatitis Eczema Eczema Atopic Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skane University Hospital

Lund, Skåne County, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Skin diseas, atopic eczema, eczema

-

Exclusion criteria

  • Inabillity to give informed concent

Treatment and study plan

Primary outcomes

  1. Skin microbiota

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    Characterization of skin microbiota are assessed at skin of patients with eczema or skin disease.

  2. Skin Barrier impairment tewl

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    measurement of trans epidermal water loss (g/m2h)

  3. EASI

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    Eczema area and severity index are assessed (score 0-72)

  4. Patient oriented outcome measures RECAP

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    Recap of atopic eczema, RECAP. RECAP is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities.

  5. Patient oriented outcome measures POEM

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    The Patient Oriented Eczema Measure (POEM) is a tool used for monitoring atopic eczema severity. It focuses on the illness as experienced by the patient.

  6. Patient oriented outcome measures DLQI

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease.

  7. Patient oriented outcome measures NRS Itch

    Time frame: At baseline/enrollment through study completion, an average of 1 year.

    The Peak Pruritus Numerical Rating Scale (NRS) is a well-defined, reliable, fit-for-purpose measure to evaluate patient-reported intensity of worst itch in the previous 24 h for adults with moderate-to-severe atopic dermatitis.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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