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

Pierre Fabre Dermo Cosmetique17 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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