NCT07017348Completed

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

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

Source: ClinicalTrials.gov · Last updated 12 Jun 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 50 (actual)
First submitted: 14 May 2025
Start date: 25 Feb 2025
Primary completion date: 27 May 2025
Lead sponsor: Pierre Fabre Dermo Cosmetique
Diseases: Atopic dermatitis (eczema)
NCT number: NCT07017348

What you commit to

Study type: Interventional
Participants enrolled: 50
From 25 Feb 2025 to the primary completion date, 27 May 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Skin Research Center Coordinator of this site? Confirm its status	Toulouse	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.