Atopic DermatitisNCT07017348
Assessment of Clinical, Biological and Biometrological Parameters in Adults Subjects With Atopic Dermatitis
A study testing Clinical assessments, Biometrological measurements and Biological sampling in people with Atopic Dermatitis and Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
In most recent years, the gut microbiome has been highlighted as a key player in the control of organs distant from the gut. Indeed, studies have raised evidence that gut microbiota exerts a control on various diseases including joint, cardiovascular, metabolic, or skin diseases, and even mental health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Healthy
- What is being tested?
- Clinical assessments, Biometrological measurements and Biological sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2025to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Criteria related to the population:
- Female
- Subject aged of 18 years old and over
- Subject non-menopausal
- For woman of childbearing potential:
- use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 1 month before inclusion in the study
Show all 45Show fewer
- accept to go on using it during the whole duration of the study
- Criteria related to the diseases and/or skin conditions:
- Specific for the AD group:
- Subject with atopic dermatitis according to "The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis"
- Subject with moderate atopic dermatitis with a SCORAD between 25 and 40 included
- Subject with target areas on the upper or lower limbs allowing sampling and measurements, defined as:
- Area of usual atopic dermatitis flare-up with at least one inflammatory flare-up of AD in the year preceding the inclusion visit
- Area not in actual flare-up but with the following L-SCORAD signs (18-point scale):
- Erythema score ≥ 1 on a scale ranged from 0 to 3
- Xerosis score ≥ 1 on a scale ranged from 0 to 3
- Specific for the CTRL group:
- Subject without inflammatory dermatological conditions (skin and scalp)
- Non-inclusion criteria
- Criteria related to the population:
- For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
- Subject having received on target areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 weeks before the inclusion visit
- Subject hirsute on the target areas
- Subject who has shaved or waxed the target areas within the last 2 days before the inclusion visit
- Criteria related to the diseases and/or skin conditions:
- Subject having a dermatological condition (excepted AD for atopic dermatitis group), an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements
- Subject having any other dermatologic condition than atopic dermatitis (for AD group), or characteristics (like tattoo) on the target areas liable to interfere with the study assessments according to the judgement of the investigator
- Subject with intestinal diseases or food allergies liable to interfere with the study, in the opinion of the investigator
- Specific for the atopic dermatitis group:
- Subject with a flare-up of AD (requiring a topical or systemic medical treatment in the opinion of the investigator)
- Subject with superinfected AD
- Criteria related to treatments and/or products:
- Systemic immunosuppressive treatment (except corticosteroids) taken within 3 months before the inclusion visit or planned during the study
- Systemic antibiotics treatment taken within 4 weeks before the inclusion visit or planned during the study
- Dietary supplements or probiotics taken within 4 weeks before the inclusion visit or planned during the study
- Systemic corticosteroids treatment taken within 4 weeks before the inclusion visit or planned during the study
- Laxative taken within 4 weeks before the inclusion visit or planned during the study
- Phototherapy within 4 weeks before the inclusion visit or planned during the study
- Colonoscopy within 4 weeks before the inclusion visit or planned during the study
- Systemic treatment with NSAID taken in the 7 days prior to the inclusion visit or ongoing at the inclusion visit (from 3 days of intake)
- Topical corticosteroids treatment applied on target areas within 7 days before the inclusion visit or planned during the study
- Topical immunomodulating treatment applied on target areas within 7 days before the inclusion visit or planned during the study
- Topical treatment with NSAID applied on target areas within 7 days before the inclusion visit or planned during the study
- Topical emollient applied on target areas within the last 48h before the inclusion visit
- Any treatment, topical product (excepted emollient) and/or water applied on target areas between the last shower (maximum the evening before inclusion visit) and the inclusion visit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Exploratory Study to Better Understand the Gut-Skin Axis in Subjects With Moderate Atopic Dermatitis and Control Subjects
In most recent years, the gut microbiome has been highlighted as a key player in the control of organs distant from the gut. Indeed, studies have raised evidence that gut microbiota exerts a control on various diseases including joint, cardiovascular, metabolic, or skin diseases, and even mental health.
Many of these effects are attributed to the role of microbiota in controlling intestinal mucosa immunity. For skin diseases, and in particular for Atopic Dermatitis (AD), it has been suggested that the imbalance of the gut microbiome affects systemic inflammation and immune response, which leads to an exacerbation of AD. Complementary to a gut-driven activation of systemic immunity, a role for the nervous system, or even for hormonal pathways can also be envisioned as contributors to the effects of gut microbiome on AD.
Read more
Understanding how the gut microbiome controls skin biology, whether it involves or not the immune system, still requires extensive translational research. A better knowledge of the actors and markers of the Gut-Skin axis is therefore necessary to understand the exact mechanisms by which the gut microbiome influences or aggravates AD symptoms.
The study will be conducted in adult subjects, divided into 2 groups:
- Group AD: subjects with moderate atopic dermatitis
- Group CTRL: subjects with no inflammatory dermatological pathology
Number of visits:
2 visits maximum are planned for both groups:
- Visit 1: Inclusion ± end-of-study visit (Day 1)
- Collection phase at home*: 1 to 5 days (Day 1 to Day 6)
- Visit 2**: End-of-study visit (Day 2 to Day 6) (maximum 24h after faecal sampling at home)
- If faecal sampling was not possible during the inclusion visit, the kit will be kept by the subject to collect the sample at home.
- Only if the faecal sampling is carried out at home.
The maximal duration of participation for a subject is 6 days from the inclusion visit to the end of the study.
- Conditions
- Atopic Dermatitis, Healthy
- Being tested
- Clinical assessments, Biometrological measurements, Biological sampling, Questionnaires
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentsOther
dermatitis atopic scores will be evaluated on the entire body and on target areas by the investigator
Biometrological measurementsOther
Measurements will be performed on the target areas
Biological samplingOther
Skin and faecal samples will be performed
QuestionnairesOther
dietary habits, health and lifestyle, and digestive health
| Study group | Role | What they receive |
|---|---|---|
| Control subject group | Other | Not described Receives: Other: Biometrological measurements; Other: Biological sampling; Other: Questionnaires |
| Subject group with moderate atopic dermatitis | Other | Not described Receives: Other: Clinical assessments; Other: Biometrological measurements; Other: Biological sampling; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic dermatitis severity on the entire body
by SCORAD on a scale 0 to 103 in atopic dermatitis group only
Measured: baseline (Visit 1- Day 1)
Atopic dermatitis severity on target areas
by L-SCORAD on a scale 0 to 18 in atopic dermatitis group only
Measured: baseline (Visit 1- Day 1)
Cutaneous pH measurement
by pH - pHmeter
Measured: baseline (Visit 1- Day 1)
Cutaneous hydration
by Hydration Index (IH) - Corneometer®
Measured: baseline (Visit 1- Day 1)
Cutaneous barrier integrity
by Trans-Epidermal Water Loss (TEWL) - Vapometer®
Measured: baseline (Visit 1- Day 1)
Microbiota analysis by sampling method with swab by gene sequencing data
Measured: baseline (Visit 1- Day 1)
Microbiota analysis by sampling method with feces by gene sequencing data
Measured: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Metabolites analysis by sampling method with swab by metabolomic technics with mass spectrometry
Measured: baseline (Visit 1- Day 1)
Metabolites analysis by sampling method with feces by metabolomic technics with mass spectrometry
Measured: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Lipids analysis by sampling method with swab by absolute quantification with mass spectrometry
Measured: baseline (Visit 1- Day 1)
Proteins analysis by sampling method with feces by metaproteomics workflow with mass spectrometry
Measured: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Proteins analysis by sampling method with swab by metaproteomics workflow with mass spectrometry
Measured: baseline (Visit 1- Day 1)
Digestive health by a questionnaire in both groups on digestive discomfort and abdominal pain
Measured: baseline (Visit 1- Day 1)
Dietary habits, health and life by a questionnaire in both groups on diet, consumption of foods, health and lifestyle
Measured: baseline (Visit 1- Day 1)
Illustrative photographs of target areas in atopic dermatitis group only
The standardized photographs of target areas in the atopic dermatitis group are intended solely for illustrative purposes. They do not serve as a quantitative measure.
Measured: baseline (Visit 1- Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start25 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017348
- Sponsor's protocol ID
- GUTSKIN
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Exploratory Study to Better Understand the Gut-Skin Axis in Subjects With Moderate Atopic Dermatitis and Control Subjects
- ClinicalTrials.gov ID
- NCT07017348
- Acronym / sponsor ID
- GUTSKIN
- Conditions
- Atopic Dermatitis, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 12 Jun 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.
In most recent years, the gut microbiome has been highlighted as a key player in the control of organs distant from the gut. Indeed, studies have raised evidence that gut microbiota exerts a control on various diseases including joint, cardiovascular, metabolic, or skin diseases, and even mental health.
Many of these effects are attributed to the role of microbiota in controlling intestinal mucosa immunity. For skin diseases, and in particular for Atopic Dermatitis (AD), it has been suggested that the imbalance of the gut microbiome affects systemic inflammation and immune response, which leads to an exacerbation of AD. Complementary to a gut-driven activation of systemic immunity, a role for the nervous system, or even for hormonal pathways can also be envisioned as contributors to the effects of gut microbiome on AD.
Understanding how the gut microbiome controls skin biology, whether it involves or not the immune system, still requires extensive translational research. A better knowledge of the actors and markers of the Gut-Skin axis is therefore necessary to understand the exact mechanisms by which the gut microbiome influences or aggravates AD symptoms.
The study will be conducted in adult subjects, divided into 2 groups:
- Group AD: subjects with moderate atopic dermatitis
- Group CTRL: subjects with no inflammatory dermatological pathology
Number of visits:
2 visits maximum are planned for both groups:
- Visit 1: Inclusion ± end-of-study visit (Day 1)
- Collection phase at home*: 1 to 5 days (Day 1 to Day 6)
- Visit 2**: End-of-study visit (Day 2 to Day 6) (maximum 24h after faecal sampling at home)
- If faecal sampling was not possible during the inclusion visit, the kit will be kept by the subject to collect the sample at home.
- Only if the faecal sampling is carried out at home.
The maximal duration of participation for a subject is 6 days from the inclusion visit to the end of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control subject group | Other | Other: Biometrological measurements, Other: Biological sampling, Other: Questionnaires |
| Subject group with moderate atopic dermatitis | Other | Other: Clinical assessments, Other: Biometrological measurements, Other: Biological sampling, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Female
- Subject aged of 18 years old and over
- Subject non-menopausal
- For woman of childbearing potential:
- Subject with atopic dermatitis according to "The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis"
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentsdermatitis atopic scores will be evaluated on the entire body and on target areas by the investigator | Other | Subject group with moderate atopic dermatitis |
| Biometrological measurementsMeasurements will be performed on the target areas | Other | Control subject group, Subject group with moderate atopic dermatitis |
| Biological samplingSkin and faecal samples will be performed | Other | Control subject group, Subject group with moderate atopic dermatitis |
| Questionnairesdietary habits, health and lifestyle, and digestive health | Other | Control subject group, Subject group with moderate atopic dermatitis |
Primary outcome
Atopic dermatitis severity on the entire body
Time frame: baseline (Visit 1- Day 1)
by SCORAD on a scale 0 to 103 in atopic dermatitis group only
Atopic dermatitis severity on target areas
Time frame: baseline (Visit 1- Day 1)
by L-SCORAD on a scale 0 to 18 in atopic dermatitis group only
Cutaneous pH measurement
Time frame: baseline (Visit 1- Day 1)
by pH - pHmeter
Cutaneous hydration
Time frame: baseline (Visit 1- Day 1)
by Hydration Index (IH) - Corneometer®
Cutaneous barrier integrity
Time frame: baseline (Visit 1- Day 1)
by Trans-Epidermal Water Loss (TEWL) - Vapometer®
Microbiota analysis by sampling method with swab by gene sequencing data
Time frame: baseline (Visit 1- Day 1)
Microbiota analysis by sampling method with feces by gene sequencing data
Time frame: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Metabolites analysis by sampling method with swab by metabolomic technics with mass spectrometry
Time frame: baseline (Visit 1- Day 1)
Metabolites analysis by sampling method with feces by metabolomic technics with mass spectrometry
Time frame: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Lipids analysis by sampling method with swab by absolute quantification with mass spectrometry
Time frame: baseline (Visit 1- Day 1)
Proteins analysis by sampling method with feces by metaproteomics workflow with mass spectrometry
Time frame: baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6)
Proteins analysis by sampling method with swab by metaproteomics workflow with mass spectrometry
Time frame: baseline (Visit 1- Day 1)
Digestive health by a questionnaire in both groups on digestive discomfort and abdominal pain
Time frame: baseline (Visit 1- Day 1)
Dietary habits, health and life by a questionnaire in both groups on diet, consumption of foods, health and lifestyle
Time frame: baseline (Visit 1- Day 1)
Illustrative photographs of target areas in atopic dermatitis group only
Time frame: baseline (Visit 1- Day 1)
The standardized photographs of target areas in the atopic dermatitis group are intended solely for illustrative purposes. They do not serve as a quantitative measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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. This study is not recruiting at the moment.
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?
A study testing Clinical assessments, Biometrological measurements and Biological sampling in people with Atopic Dermatitis and Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
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 45 inclusion and 0 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: finished, as of the sponsor's last update on 12 Jun 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Atopic dermatitis severity on the entire body (time frame: baseline (Visit 1- Day 1)). The study lists 15 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 12 Jun 2025.