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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05639738
• Other study ID #: ADFLAREPREDICT
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2022
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Other:
• Clinical and instrumental measurements
Clinical evaluations Non-invasive instrumental measurements Subject's evaluations

Locations

Country	Name	City	State
France	Centre de Recherche sur la Peau	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Assessment of pH in Atopic Dermatitis during and outside flares-up	pH evaluated by a pH-meters	Change from baseline to 3 months
Primary	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