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

Completed

• Conditions: Mild to Moderate Atopic Dermatitis

• Registration Number: NCT07166497
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

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:

* Visit 1 - Day 1 - Inclusion visit

* Visit 2 - Day 8 - Intermediate visit

* Visit 3 - Day 29 (± 3 days) - Intermediate visit

* Visit 4 - Day 36 (± 3 days) - End of study visit

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The pruritus severity with VAS (Visual Analog Scale) 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	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	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)	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	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	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	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	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	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	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	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	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	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	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)	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	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	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	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

Trial Locations

Locations (1)

Skin Research Center; 🇫🇷 Toulouse, France, France