Assessment of Clinical, Biological and Biometrological Pa... | NCT05639738

NCT05639738

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
All subject	Other	Clinical and instrumental measurements	Other: Clinical and instrumental measurements

Name	Type	Description	Arm Group Labels	Other Names
Clinical and instrumental measurements	Other	Clinical evaluations Non-invasive instrumental measurements Subject's evaluations	All subject

Outcomes Module

Primary Outcomes

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

Eligibility Module

Eligibility Criteria

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

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis