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

NCT07017348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-12

No results posted yet for this study

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.

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.

Conditions

Interventions

OTHER

Clinical assessments

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

OTHER

Biometrological measurements

Measurements will be performed on the target areas

OTHER

Biological sampling

Skin and faecal samples will be performed

OTHER

Questionnaires

dietary habits, health and lifestyle, and digestive health

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-05-27
Completion
2025-05-27

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017348 on ClinicalTrials.gov