Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change on instrumental measurement performed by investigational team : TEWL
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only most important inclusion and
排除标准
- •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
结局指标
主要结局
Change on instrumental measurement performed by investigational team : TEWL
时间窗: Day1, Day29, Day57 and Day85
TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin
Change on clinical evaluation (investigator evaluation) : SCORAD
时间窗: 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
时间窗: 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 : Lipidic analysis
时间窗: 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 instrumental measurement performed by investigational team : cutaneous hydration
时间窗: 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
时间窗: 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 Subject's evaluation : subject evaluation
时间窗: once a month
Subject's questionnaire on lifestyle modifications, as potential flare triggers.
Change on instrumental measurement by subject
时间窗: each day, during 3 months
hydration index : mean value measured by a measuring pen on the skin
Change on Subject's evaluations : subject evaluation
时间窗: 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.
次要结局
未报告次要终点