Skin DiseaseNCT06924333
The Skin Microbiota in Skin Disease and Eczema
An observational study of Skin Disease and Eczema, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Disease, Eczema, Eczema Atopic Dermatitis
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2025to 20 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patints with skin diseases, atopic eczema and eczema. Healthy volonteers.
Who may be able to join
- -
Who cannot join
- Inabillity to give informed concent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Skin Disease, Eczema, Eczema Atopic Dermatitis
- Medical subject headings
- Skin Diseases, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with atopic eczema, eczema or other skin diseases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin microbiota
Characterization of skin microbiota are assessed at skin of patients with eczema or skin disease.
Measured: At baseline/enrollment through study completion, an average of 1 year.
Skin Barrier impairment tewl
measurement of trans epidermal water loss (g/m2h)
Measured: At baseline/enrollment through study completion, an average of 1 year.
EASI
Eczema area and severity index are assessed (score 0-72)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline/enrollment through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start20 Jan 2025
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseaseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924333
- Sponsor's protocol ID
- 2024-06196-02
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If confidential
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Skin Microbiota in Skin Disease and Eczema
- ClinicalTrials.gov ID
- NCT06924333
- Acronym / sponsor ID
- 2024-06196-02
- Conditions
- Skin Disease, Eczema, Eczema Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 11 Apr 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with atopic eczema, eczema or other skin diseases | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patints with skin diseases, atopic eczema and eczema. Healthy volonteers.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Inabillity to give informed concent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
EASI
Time frame: At baseline/enrollment through study completion, an average of 1 year.
Eczema area and severity index are assessed (score 0-72)
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided. If confidential
Related trials for Skin Disease
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Disease and Eczema, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Skin microbiota (time frame: At baseline/enrollment through study completion, an average of 1 year.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.