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

Pierre Fabre

Status

Terminated

Conditions

Dermatitis, Atopic

Treatments

Other: Clinical and instrumental measurements

Study type

Interventional

Funder types

Industry

Identifiers

NCT05639738

ADFLAREPREDICT

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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