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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Clinical evaluations; Other: Non-invasive instrumental measurements; Other: Subject's evaluations

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31300
    • Skin Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All Subjects; Clinical and instrumental measurements	Other: Clinical evaluations; SCORAD and target SCORAD; Other: Non-invasive instrumental measurements; TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index; Other: Subject's evaluations; PO-SCORAD, target PO-SCORAD and subject's questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Didier COUSTOU, MD

Publications and helpful links

Helpful Links

• free mobile app: PO-Scorad®

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: POSCORADCOLLECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No