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

Not Applicable

Terminated

• Conditions: Dermatitis, Atopic
• Interventions: Other: Clinical and instrumental measurements

• Registration Number: NCT05639738
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Study First Submitted: 2022-09-16
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subject	Clinical and instrumental measurements	Clinical and instrumental measurements

Primary Outcome Measures

Name	Time	Method
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up	Change from baseline to 3 months	The measurement is based on Trans-Epidermal Water Loss measurement
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples	Change from baseline to 3 months	Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up	Change from baseline to 3 months	* 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
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up	Change from baseline to 3 months	Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Assessment of erythema in Atopic Dermatitis during and outside flares-up	Change from baseline to 3 months	Assessment the color of the surface of the skin
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample	Change from baseline to 3 months	Colonization of microorganisms will be expressed by percentage of each microorganism
Assessment of pH in Atopic Dermatitis during and outside flares-up	Change from baseline to 3 months	pH evaluated by a pH-meters

Trial Locations

Locations (1)

Centre de Recherche sur la Peau; 🇫🇷 Toulouse, France