Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis
NCT ID: NCT04553224
Last Updated: 2020-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2019-11-12
2020-02-10
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All Subjects
Clinical and instrumental measurements
Clinical evaluations
SCORAD and target SCORAD
Non-invasive instrumental measurements
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
Subject's evaluations
PO-SCORAD, target PO-SCORAD and subject's questionnaire
Interventions
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Clinical evaluations
SCORAD and target SCORAD
Non-invasive instrumental measurements
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
Subject's evaluations
PO-SCORAD, target PO-SCORAD and subject's questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
No
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Responsible Party
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Principal Investigators
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Didier COUSTOU, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Skin Research Centre
Toulouse, , France
Countries
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Related Links
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free mobile app: PO-Scorad®
Other Identifiers
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POSCORADCOLLECT
Identifier Type: -
Identifier Source: org_study_id
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