NCT07017348

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Atopic Dermatitis
• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: France