Atopic Dermatitis
Conditions
Brief summary
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.
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
Interventions
OTHERClinical evaluations
SCORAD and target SCORAD
OTHERNon-invasive instrumental measurements
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
OTHERSubject's evaluations
PO-SCORAD, target PO-SCORAD and subject's questionnaire
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on instrumental measurement performed by investigational team : Lipidic analysis | 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 |
| Change on clinical evaluation (investigator evaluation) : SCORAD | Day1, Day29, Day57 and Day85 | The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner |
| Change on clinical evaluation (investigator evaluation) : Target SCORAD | 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 |
| Change on instrumental measurement performed by investigational team : TEWL | Day1, Day29, Day57 and Day85 | TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin |
| Change on instrumental measurement performed by investigational team : cutaneous hydration | 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. |
| Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema | 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. |
| Change on instrumental measurement by subject | each day, during 3 months | hydration index : mean value measured by a measuring pen on the skin |
| Change on Subject's evaluations : subject evaluation | 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. |
| Change on Subject's evaluation : subject evaluation | 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 |
Countries
France
Outcome results
None listed