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Completed

NCT Number: NCT07017348

Assessment of Clinical, Biological and Biometrological Parameters in Adults Subjects With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skin Research Center

Toulouse, 31300, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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
  • 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

Treatment and study plan

clinical assessments

Other

dermatitis atopic scores will be evaluated on the entire body and on target areas by the investigator

Biometrological measurements

Other

Measurements will be performed on the target areas

Biological sampling

Other

Skin and faecal samples will be performed

questionnaires

Other

dietary habits, health and lifestyle, and digestive health

Primary outcomes

  1. 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

  2. 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

  3. Cutaneous pH measurement

    Time frame: baseline (Visit 1- Day 1)

    by pH - pHmeter

  4. Cutaneous hydration

    Time frame: baseline (Visit 1- Day 1)

    by Hydration Index (IH) - Corneometer®

  5. Cutaneous barrier integrity

    Time frame: baseline (Visit 1- Day 1)

    by Trans-Epidermal Water Loss (TEWL) - Vapometer®

  6. Microbiota analysis by sampling method with swab by gene sequencing data

    Time frame: baseline (Visit 1- Day 1)

  7. 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)

  8. Metabolites analysis by sampling method with swab by metabolomic technics with mass spectrometry

    Time frame: baseline (Visit 1- Day 1)

  9. 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)

  10. Lipids analysis by sampling method with swab by absolute quantification with mass spectrometry

    Time frame: baseline (Visit 1- Day 1)

  11. 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)

  12. Proteins analysis by sampling method with swab by metaproteomics workflow with mass spectrometry

    Time frame: baseline (Visit 1- Day 1)

  13. Digestive health by a questionnaire in both groups on digestive discomfort and abdominal pain

    Time frame: baseline (Visit 1- Day 1)

  14. 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)

  15. 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.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

Knowledge and Exploratory Study to Better Understand the Gut-Skin Axis in Subjects With Moderate Atopic Dermatitis and Control Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

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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