Clinical trial NCT05639738: Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD
Official title: An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up
timeFrame: Change from baseline to 3 months
measure: Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample
timeFrame: Change from baseline to 3 months
measure: Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples
timeFrame: Change from baseline to 3 months
measure: Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up
timeFrame: Change from baseline to 3 months
measure: Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up
timeFrame: Change from baseline to 3 months
measure: Assessment of pH in Atopic Dermatitis during and outside flares-up
timeFrame: Change from baseline to 3 months
measure: Assessment of erythema in Atopic Dermatitis during and outside flares-up
timeFrame: Change from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre de Recherche sur la Peau
Study officials:
References: