Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis

NCT04553224 | Completed

• 1 other identifier: POSCORADCOLLECT
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease. The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects. The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (10)

• Change on clinical evaluation (investigator evaluation) : SCORAD

  The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner

  Day1, Day29, Day57 and Day85

• Change on clinical evaluation (investigator evaluation) : Target SCORAD

  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

  Day1, Day29, Day57 and Day85

• Change on instrumental measurement performed by investigational team : TEWL

  TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin

  Day1, Day29, Day57 and Day85

• Change on instrumental measurement performed by investigational team : Lipidic analysis

  The proportion of lipids will be analysed on specific bands of infrared spectra by calculation of area under curve of the peaks

  Day1, Day29, Day57 and Day85

• Change on instrumental measurement performed by investigational team : cutaneous hydration

  Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.

  Day1, Day29, Day57 and Day85

• Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema

  Evaluation with objective assessment the color of the surface of the skin. Data output will be in the form of the L\* a\* b\* color coordinate system. The a\* values (red/ green) will be assessed for quantifying the degree of erythema.

  Day1, Day29, Day57 and Day85

• Change on instrumental measurement by subject

  hydration index : mean value measured by a measuring pen on the skin

  each day, during 3 months

• Change on Subject's evaluations : subject evaluation

  PO-SCORAD : a fully validated self-assessment of the AD severity adapted from the SCORAD index; it is available on mobile's phone application.

  each day during 3 months

• Change on Subject's evaluation : subject evaluation

  target PO-SCORAD : The target PO-SCORAD is the sum of all PO-SCORAD objective signs scores: dryness of the skin without eczema, redness of the skin affected by eczema, swelling, oozing/ crust, scratching and thickening evaluated on the target area

  on Day1, Day29, Day57 and Day85

• Change on Subject's evaluation : subject evaluation

  Subject's questionnaire on lifestyle modifications, as potential flare triggers.

  once a month

Study Arms (1)

All Subjects

OTHER

Clinical and instrumental measurements

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

Interventions

Clinical evaluations OTHER

SCORAD and target SCORAD

All Subjects

Non-invasive instrumental measurements OTHER

TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index

All Subjects

Subject's evaluations OTHER

PO-SCORAD, target PO-SCORAD and subject's questionnaire

All Subjects

Eligibility Criteria

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

You may not qualify if:

• Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3).
• Subject with flare frequency ≥ 4 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 owning a smartphone suitable with the 5.0 downloaded version of PO-Scorad® app
• Subject who agrees to use daily a free mobile app: PO-Scorad®
• Subject with a hirsute target area

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Centre

Toulouse, 31300, France

Location

Related Links

• free mobile app: PO-Scorad®

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 Officials

• Didier COUSTOU, MD

  PRINCIPAL INVESTIGATOR

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: May 14, 2020
• First Posted: September 17, 2020
• Study Start: November 12, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)