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

Pierre Fabre

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: Non-invasive instrumental measurements

Other: Clinical evaluations

Other: Subject's evaluations

Study type

Interventional

Funder types

Industry

Identifiers

NCT04553224

POSCORADCOLLECT

Details and patient eligibility

About

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.

Full 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

Enrollment

17 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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