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

NCT05639738 | Terminated

• 1 other identifier: ADFLAREPREDICT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (7)

• 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

  Change from baseline to 3 months

• 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

Study Arms (1)

All subject

OTHER

Clinical and instrumental measurements

Other: Clinical and instrumental measurements

Interventions

Clinical and instrumental measurements OTHER

* Clinical evaluations * Non-invasive instrumental measurements * Subject's evaluations

All subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Centre de Recherche sur la Peau

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: December 6, 2022
• Study Start: March 8, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

FR (1)