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OpenTrials
Completed

NCT Number: NCT04553224

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin Research Centre

Toulouse, 31300, France

About this study

This study will be conducted as a French monocentric exploratory study in adults with mild to moderate Atopic Dermatitis, and will be conducted on a maximum 25 included subjects.

The clinical study will include 4 study visits, after inclusion visit, and the maximum duration of the study for each subject will be 3 months : Day 1, Day 29, Day 57, Day 85.

In case of AD flare suspicion, the investigator may recommend a complementary visit. Any complementary visit will be confirmed by investigator according to the subject's information: photographs and PO-SCORAD sent by the subject. If visit is confirmed, it will be scheduled as soon as possible.

The objectives are:

  • to collect clinical AD severity data in order to evaluate natural AD evolution with clinical and subject's scales, during a three-month period.
  • to collect non-invasive instrumental AD data on a target area and on adjacent area: cutaneous hydration, epidermal barrier conditions and colorimetric parameters on cutaneous erythema
  • to examine clinical and instrumental AD data
  • to collect illustrative photographs of AD lesions

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Only most important inclusion and exclusion criteria are listed : those which are study specific.

Inclusion criteria

  • Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3).
  • Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
  • 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®

Exclusion criteria

  • Subject having received artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit or planning to be exposed to excessive or prolonged natural sunlight or UV exposures for the duration of the study
  • Subject with a hirsute target area
  • Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit.
  • Systemic corticoids taken (whatever the number of intake) within 4 weeks before the inclusion visit or ongoing at inclusion visit.
  • Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit
  • Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit.
  • Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
  • Topical immunomodulators (TIMs), applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
  • Any topical treatment or product applied between the evening before the inclusion visit and the inclusion visit
  • Water applied on target area within 4 hours before the inclusion visit

Treatment and study plan

Clinical evaluations

Other

SCORAD and target SCORAD

Non-invasive instrumental measurements

Other

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

Subject's evaluations

Other

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

Primary outcomes

  1. Change on clinical evaluation (investigator evaluation) : SCORAD

    Time frame: Day1, Day29, Day57 and Day85

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

  2. Change on clinical evaluation (investigator evaluation) : Target SCORAD

    Time frame: Day1, Day29, Day57 and Day85

    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

  3. Change on instrumental measurement performed by investigational team : TEWL

    Time frame: Day1, Day29, Day57 and Day85

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

  4. Change on instrumental measurement performed by investigational team : Lipidic analysis

    Time frame: Day1, Day29, Day57 and Day85

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

  5. Change on instrumental measurement performed by investigational team : cutaneous hydration

    Time frame: Day1, Day29, Day57 and Day85

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

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

    Time frame: Day1, Day29, Day57 and Day85

    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.

  7. Change on instrumental measurement by subject

    Time frame: each day, during 3 months

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

  8. Change on Subject's evaluations : subject evaluation

    Time frame: each day during 3 months

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

  9. Change on Subject's evaluation : subject evaluation

    Time frame: on Day1, Day29, Day57 and Day85

    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

  10. Change on Subject's evaluation : subject evaluation

    Time frame: once a month

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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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