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

NCT07017348 | Completed

• 1 other identifier: GUTSKIN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (15)

• Atopic dermatitis severity on the entire body

  by SCORAD on a scale 0 to 103 in atopic dermatitis group only

  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

  baseline (Visit 1- Day 1)

• Cutaneous pH measurement

  by pH - pHmeter

  baseline (Visit 1- Day 1)

• Cutaneous hydration

  by Hydration Index (IH) - Corneometer®

  baseline (Visit 1- Day 1)

• Cutaneous barrier integrity

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

  baseline (Visit 1- Day 1)

• Microbiota analysis by sampling method with swab by gene sequencing data

  baseline (Visit 1- Day 1)

• Microbiota analysis by sampling method with feces by gene sequencing data

  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

  baseline (Visit 1- Day 1)

• Metabolites analysis by sampling method with feces by metabolomic technics with mass spectrometry

  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

  baseline (Visit 1- Day 1)

• Proteins analysis by sampling method with feces by metaproteomics workflow with mass spectrometry

  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

  baseline (Visit 1- Day 1)

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

  baseline (Visit 1- Day 1)

• Dietary habits, health and life by a questionnaire in both groups on diet, consumption of foods, health and lifestyle

  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.

  baseline (Visit 1- Day 1)

Study Arms (2)

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

Interventions

Clinical assessments OTHER

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

Subject group with moderate atopic dermatitis

Biometrological measurements OTHER

Measurements will be performed on the target areas

Control subject group; Subject group with moderate atopic dermatitis

Biological sampling OTHER

Skin and faecal samples will be performed

Control subject group; Subject group with moderate atopic dermatitis

Questionnaires OTHER

dietary habits, health and lifestyle, and digestive health

Control subject group; Subject group with moderate atopic dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria related to the population:
• Female
• Subject aged of 18 years old and over
• Subject non-menopausal
• For woman of childbearing potential:
• 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 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 12, 2025
• Study Start: February 25, 2025
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

FR (1)