The Skin Microbiota in Skin Disease and Eczema

NCT06924333 | Enrolling By Invitation

• 1 other identifier: 2024-06196-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Disease; Eczema; Eczema Atopic Dermatitis

Outcome Measures

Primary Outcomes (7)

• Skin microbiota

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

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

• Skin Barrier impairment tewl

  measurement of trans epidermal water loss (g/m2h)

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

• EASI

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

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

• Patient oriented outcome measures RECAP

  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.

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

• Patient oriented outcome measures POEM

  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.

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

• Patient oriented outcome measures DLQI

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

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

• Patient oriented outcome measures NRS Itch

  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.

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

Study Arms (1)

Patient with atopic eczema, eczema or other skin diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patints with skin diseases, atopic eczema and eczema. Healthy volonteers.

You may not qualify if:

• Inabillity to give informed concent

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital

Lund, Skåne County, 22185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin microbiota, skin specimens, blood samples.

MeSH Terms

Conditions

Skin Diseases; Eczema

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: April 11, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

SE (1)