Evaluation of the Effect of the Product RV4660C CY0203 on Clinical, Biometrological and Biological Parameters in Adults With Mild to Moderate Atopic Dermatitis, an Exploratory Study

The pruritus severity with VAS (Visual Analog Scale) over the last 24 hours

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of pruritus severity using a VAS (continuous sliding scale from 0 cm = no itching to 10 cm = worst itching imaginable) over the last 24 hours

The quality of sleep using connected watch

时间窗: Before products' application from Day 1 to Day 7 and after 21 consecutive days of products' application from Day 8 to Day 29.

Measurement of sleep parameters using a connected watch worn on the wrist by the subjects

The quality of sleep with VAS (Visual Analog Scale)

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of quality of sleep using a VAS (continuous sliding scale from 0 cm = no sleep disturbance to 10 cm = worst sleep disturbance imaginable) over the last 72 hours using the SCORAD scale

The quality of sleep with the Chronic itch burden scale

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of quality of sleep using the question n°4 from the Chronic Itch Burden Scale questionnaire

The quality of sleep with the Sleep Health index

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of quality of sleep using the questions n°6 to 10 from the Sleep Health index

The quality of sleep using Insomnia Severity Index (ISI) questionnaire

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of the quality of sleep

The scratch using a connected watch

时间窗: Before products' application from Day 1 to Day 7 and after 21 consecutive days of products' application from Day 8 to Day 29.

Measurement of scratch using a connected watch worn on the wrist by the subjects

The pruritus severity with VAS (Visual Analog Scale) over the last 72 hours

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of pruritus severity using a VAS (continuous sliding scale from 0 cm = no itching to 10 cm = worst itching imaginable) over the last 72 hours using the SCORAD scale

The skin hydration using a Corneometer

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation of the hydration index performed by a clinical research technician on one of the target area

The skin barrier condition using a Vapometer

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation of the trans-epidermal water loss performed by a clinical research technician on one of the target area

The skin microbiota with non-invasive skin swabs

时间窗: Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4)

Evaluation of the skin microbiota performed by a clinical research technician on one of the target areas

Metabolites produced by host and microorganisms of the skin with non-invasive skin D-Squames

时间窗: Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4)

Evaluation of the metabolites produced by host and microorganisms of the skin performed by a clinical research technician on one of the target areas

Metabolites produced by host and microorganisms of the skin with non-invasive skin swabs

时间窗: Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4)

Evaluation of the metabolites produced by host and microorganisms of the skin performed by a clinical research technician on one of the target areas

Severity of atopic dermatitis throughout the body with SCORAD (SCOring Atopic Dermatitis)

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the investigator of * The extent of the disease using the rule of nines to estimate percentage of the affected body surface area. The maximum value for the extent of the disease is 100%. * The disease intensity calculated based on six characteristics: erythema, edema, oozing/crusts, excoriations, lichenification, and dryness. Each characteristic is given a score between 0 and 3, where 0 is absent and 3 is severe. The scores for each characteristic are added together for a total intensity score of up to 18. Evaluation performed by the subject of subjective symptoms including sleep loss and pruritus using a 10 cm visual analogue scale with a total maximum score of 20. The SCORAD was then calculated with the following formula: Extent/5 + 7×Intensity/2 + Subjective Symptoms

Severity of the target atopic dermatitis areas (defined as a typical AD flare-up area in the opinion of the subject) with target SCORAD

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the investigator of severity of the target areas calculated based on six characteristics: erythema, edema, oozing/crusts, excoriations, lichenification, and dryness. Each characteristic is given a score between 0 and 3, where 0 is absent and 3 is severe. The scores for each characteristic are added together for a total intensity score of up to 18.

The pruritus severity with the Chronic itch burden scale over the past 7 days

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of pruritus severity on a NRS (0=no itching to 10=worst itching imaginable) over the past 7 days

The impact of pruritus on quality of life with the Chronic itch burden scale over the past 7 days

时间窗: Before application and before wearing the connected watch (Day 1, Visit 1), after 7 consecutive days of wearing connected watch - before application (Day 8, Visit 2), after 21 (Day 29, Visit 3) and 28 (Day 36, Visit 4) consecutive days of application

Evaluation performed by the subject of the impact of pruritus on daily life over the past 7 days with 20 questions from 0=not at all, 1=a little, 2=somewhat, 3=a lot and 4=very much