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Mild to Moderate Atopic DermatitisNCT07166497

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

An observational study of Mild to Moderate Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Mild to Moderate Atopic Dermatitis
What is being tested?
Cosmetic product RV4660C CY0203
How many people
21 participants
Where
1 siteFrance
Study dates
30 Oct 2023to 22 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

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):
  1. Erythema ≥ 1
  2. Xerosis > 1
  • Subject with pruritus intensity ≥ 3 on SCORAD analog visual scale (VAS)

Main non-inclusion criteria:

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Skin Research Center

    Toulouse, France, 31000

Other trials in France

About this study

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
Being tested
Cosmetic product RV4660C CY0203

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cosmetic product RV4660C CY0203Other

    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.

Study groups in NCT07166497
Study groupRoleWhat they receive
Test GroupNot described
Receives: Other: Cosmetic product RV4660C CY0203

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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.

    Measured: 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

  3. 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

    Measured: 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

  4. 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

    Measured: 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

  5. 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

    Measured: 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

  6. 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

    Measured: 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

  7. The quality of sleep using connected watch

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

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

  8. 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

    Measured: 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

  9. 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

    Measured: 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

  10. 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

    Measured: 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

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

    Evaluation performed by the subject of the quality of sleep

    Measured: 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

  12. The scratch using a connected watch

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

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

  13. The skin hydration using a Corneometer

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

    Measured: 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

  14. 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

    Measured: 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

  15. 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

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

  16. 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

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

  17. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start30 Oct 2023
  3. Primary completion22 Dec 2023
  4. Study completion22 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166497
Sponsor's protocol ID
RV4660C20230530
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mild to Moderate Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of atopic dermatitis throughout the body with SCORAD (SCOring Atopic Dermatitis) (time frame: 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 study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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