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

NCT07166497 | Completed

• 1 other identifier: RV4660C20230530
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (17)

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

  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

  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

• 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)

Study Arms (1)

Test Group

Other: Cosmetic product RV4660C CY0203

Interventions

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.

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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 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):
• Erythema ≥ 1
• Xerosis \> 1
• Subject with pruritus intensity ≥ 3 on SCORAD analog visual scale (VAS)
• Subject with superinfected AD
• Subject with a known history of allergy or intolerance to the components of the study product
• Subject with a dermatological condition other than AD, or characteristics (for example, tattoo) on the study areas, likely to interfere with the study evaluations according to the investigator's opinion
• Subject with another dermatological condition, acute or chronic pathology, or history of pathology, likely to interfere with study evaluations, or considered dangerous to the subject or incompatible with study requirements, in the opinion of the investigator
• Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational product according to the investigator's assessment

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, France, 31000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: October 30, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

FR (1)