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In this exploratory study, we assessed the efficacy of a cosmetic product in adults suffering from mild to moderate atopic dermatitis. This exploratory study has been conducted as a monocentric non randomized study.
To perform this clinical study, 21 non menopausal women, aged from 18 years and older, suffering from mild to moderate atopic dermatitis were enrolled.
The subjects applied the investigational product once a day, in the evening on the whole body/ off face for up to 31 days.
4 visits were planned:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product RV4660C CY0203 | Other | The product was applied once a day, in the evening, on the whole body/ off face on previously cleansed skin. The product was warmed in the hands before being applied in wide movements. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of atopic dermatitis throughout the body with SCORAD (SCOring Atopic Dermatitis) | Evaluation performed by the investigator of
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 | 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 |
| Severity of the target atopic dermatitis areas (defined as a typical AD flare-up area in the opinion of the subject) with target SCORAD | 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. | 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 |
| The pruritus severity with the Chronic itch burden scale over the past 7 days | Evaluation performed by the subject of pruritus severity on a NRS (0=no itching to 10=worst itching imaginable) over the past 7 days | 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 |
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Main inclusion criteria :
Woman 18 years or older
Non-menopausal woman
Subject with phototype I, II, III, IV as classified by Fitzpatrick
Subject with AD according to "The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis"
Mild to moderate AD with SCORAD (SCORing Atopic Dermatitis) between 20 and 40 inclusive
Subject who had at least 1 inflammatory AD flare-up in target areas in the year prior to inclusion visit
Subject with at least one measuring target area on each upper or lower limb and defined as a typical AD flare-up area in the opinion of the subject
Subject with at least one target area on each upper or lower limb with the following SCORAD target signs (between 3 and 18):
Subject with pruritus intensity ≥ 3 on SCORAD analog visual scale (VAS)
Main non-inclusion criteria:
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The study is disseminated to the database of potential subjects by email and, if needed, by telephone, describing study title,name(s), address(es) and contacts of the study site(s), name of the Principal Investigator, the parameter(s) in study, study inclusion and exclusion criteria, study objective(s), groups of treatment, namely, if experimental or comparative products are tested, potential risks of adverse events and study duration.
The subjects that manifested interest in participating in the study might be contacted by telephone.
Screening questions are asked in order to screen the main inclusion and exclusion criteria Subjects' answers to the telephonic recruitment are evaluated by the Principal Investigator who decides if the subject is to be selected for the recruitment visit.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Center | Toulouse | France | 31000 | France |
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| The impact of pruritus on quality of life with the Chronic itch burden scale over the past 7 days | 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 | 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 |
| The pruritus severity with VAS (Visual Analog Scale) over the last 72 hours | 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 | 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 |
| The pruritus severity with VAS (Visual Analog Scale) over the last 24 hours | 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 | 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 |
| The quality of sleep using connected watch | Measurement of sleep parameters using a connected watch worn on the wrist by the subjects | Before products' application from Day 1 to Day 7 and after 21 consecutive days of products' application from Day 8 to Day 29. |
| The quality of sleep with VAS (Visual Analog Scale) | 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 | 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 |
| The quality of sleep with the Chronic itch burden scale | Evaluation performed by the subject of quality of sleep using the question n°4 from the Chronic Itch Burden Scale questionnaire | 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 |
| The quality of sleep with the Sleep Health index | Evaluation performed by the subject of quality of sleep using the questions n°6 to 10 from the Sleep Health index | 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 |
| The quality of sleep using Insomnia Severity Index (ISI) questionnaire | Evaluation performed by the subject of the quality of sleep | 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 |
| The scratch using a connected watch | Measurement of scratch using a connected watch worn on the wrist by the subjects | Before products' application from Day 1 to Day 7 and after 21 consecutive days of products' application from Day 8 to Day 29. |
| The skin hydration using a Corneometer | Evaluation of the hydration index performed by a clinical research technician on one of the target area | 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 |
| The skin barrier condition using a Vapometer | Evaluation of the trans-epidermal water loss performed by a clinical research technician on one of the target area | 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 |
| The skin microbiota with non-invasive skin swabs | Evaluation of the skin microbiota performed by a clinical research technician on one of the target areas | Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4) |
| Metabolites produced by host and microorganisms of the skin with non-invasive skin D-Squames | Evaluation of the metabolites produced by host and microorganisms of the skin performed by a clinical research technician on one of the target areas | Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4) |
| Metabolites produced by host and microorganisms of the skin with non-invasive skin swabs | Evaluation of the metabolites produced by host and microorganisms of the skin performed by a clinical research technician on one of the target areas | Before product's application (Day 8, Visit 2) and after 28 consecutive days of product's application (Day 36, Visit 4) |