Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)

The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.

Study Overview

• Status: Terminated
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: Clinical and instrumental measurements

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31400
    • Centre de Recherche sur la Peau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject aged between 18 to 50 years included
• Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)
• Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
• Subject with flare frequency ≥ 4 on the target areas over the last year
• Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject

• Subject with a target area with 22 <= target SCORAD signs <= 10 following:

  • Erythema ≥ 1
  • Dryness ≥ 1 1

• Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as :

  • A non- usual AD flare area according to the subject and the investigator
  • A sufficient distance from the cutaneous target area according to the investigator

Exclusion Criteria:

• Subject with a surinfected AD
• Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
• Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator
• Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
• Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
• Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subject; Clinical and instrumental measurements	Other: Clinical and instrumental measurements; Clinical evaluations; Non-invasive instrumental measurements; Subject's evaluations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up	SCORAD (SCOring Atopic Dermatitis) and PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) are a scoring system based on the assessment of extent and intensity in a standardized manner; Target SCORAD is the sum of all SCORAD objective signs scores: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness evaluated on a target area	Change from baseline to 3 months
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample	Colonization of microorganisms will be expressed by percentage of each microorganism	Change from baseline to 3 months
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples	Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity	Change from baseline to 3 months
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up	Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.	Change from baseline to 3 months
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up	The measurement is based on Trans-Epidermal Water Loss measurement	Change from baseline to 3 months
Assessment of pH in Atopic Dermatitis during and outside flares-up	pH evaluated by a pH-meters	Change from baseline to 3 months
Assessment of erythema in Atopic Dermatitis during and outside flares-up	Assessment the color of the surface of the skin	Change from baseline to 3 months

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: ADFLAREPREDICT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No