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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Other | Clinical and instrumental measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical evaluations | Other | SCORAD and target SCORAD |
| |
| Non-invasive instrumental measurements |
| 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. |
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Only most important inclusion and exclusion criteria are listed : those which are study specific.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier COUSTOU, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Centre | Toulouse | 31300 | France |
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| Label | URL |
|---|---|
| free mobile app: PO-Scorad® | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Other |
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index |
|
| Subject's evaluations | Other | PO-SCORAD, target PO-SCORAD and subject's questionnaire |
|
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |