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HealthyNCT07208227

In-use Tolerance and Efficacy Study Under Dermatological and Ophthalmological Controls - Face Cream, RV4983A - LA3365

An observational study of Healthy and Sensitive Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

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

Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial. Read more about this study

Who is it for?
Ages 45 to 65 years, women only
Conditions the study is for
Healthy, Sensitive Skin, Deep Wrinkles
What is being tested?
Face Cream RV4983A LA3365
How many people
44 participants
Where
1 sitePoland
Study dates
27 Oct 2021to 7 Feb 2022
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 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study. They will be definitely included in the study after a specific interview and a clinical examination.

Who may be able to join

  • Criteria related to the population:
  • female
  • aged between 45 and 65 years included
  • phototype: I to III
  • skin type: oily, combination, normal, dry, very dry
  • 100% of subjects with sensitive skin on the face
Show all 44Show fewer
  • 100% of subjects with deep wrinkles on the face
  • 100% of subjects with sagging skin on the face
  • 100% of subjects with dull and uneven complexion
  • subjects must be registered with health social security or health social insurance
  • having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
  • certifying the truth of the personal information declared to the Investigator
  • able to understand the language used in the investigation centre and the information given
  • able to comply with the protocol and follow protocol's constraints and specific requirements
  • a maximum of 20% of subjects being lens wearers will be included in the study
  • subject agree to not expose herself to sunlight or UV during the study and if necessary, provide sun protection
  • Criteria related to subject's health:
  • considered "healthy subject" by the Investigator
  • women of childbearing potential committing themselves to use effective contraceptive method throughout the study and for at least 3 months before the inclusion visit
  • NON INCLUSION CRITERIA
  • Criteria related to the population:
  • having participated in another clinical trial within the week before the inclusion visit and for a longer period if required in the Investigator's opinion
  • taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
  • deprived of freedom by administrative or legal decision or under guardianship
  • not able to be contacted in case of emergency
  • admitted in a sanitary or social facilities o planning an hospitalization during the study
  • belonging to the staff of the investigation centre
  • Criteria related to subject's health:
  • breastfeeding, pregnant (for the women of childbearing potential)
  • having a dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
  • having an ophthalmological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
  • having personal medical history liable to interfere with the study data for the subject (especially characterized cosmetic hyperreactivity) or incompatible with the study requirements (except if this population is required by the Sponsor i.e atopic dermatitis)
  • having history of abnormal reactions from exposure to sunlight
  • having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
  • being under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
  • Criteria related to investigational product application areas:
  • having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data, before the inclusion visit or foreseeing it for the duration of the study
  • having applied a skincare or make up product on the study areas the day of the inclusion visit. The usual cleanser is allowed.
  • having received, on the study areas, artificial UV exposure or excessive exposure to natural sunlight within the 1 month before the inclusion visit
  • Criteria related to the COVID-19 pandemic:
  • Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study
  • Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal or above 37,5°C
  • Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study
  • Subject who is currently during home quarantine recommended by the Sanitary Inspection

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Eurofins Dermscan Poland Sp. z o. o

    Gdansk, Poland, 80288

Other trials in Poland

About this study

Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial.

Planning of the visits:

  • Visit 1: Inclusion (Day 1)
  • Visit 2: Intermediate visit (Day 29), a window of +48 hours is allowed
  • Visit 3: End of study (Day 57), a window of +72 hours is allowed The maximum duration of participation for a subject is 60 days.
Being tested
Face Cream RV4983A LA3365
Keywords
open trial, antiaging cosmetic cream

What participants receive

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

  • Face Cream RV4983A LA3365Other

    Cosmetic face cream product applied once a day on face, neck and neckline.

Study groups in NCT07208227
Study groupRoleWhat they receive
Test groupNot described
Receives: Other: Face Cream RV4983A LA3365

What is being measured

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

  1. Global tolerance assessment

    Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product.

    Global assessment of the dermatological and ophthalmological tolerance is done by the investigator. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.

    Measured: At the end of the study, after Last Patient Out, (after Day 57)

Secondary outcomes (11)

  1. Ra parameter to evaluate smoothing/anti-wrinkle effect

    Ra= Average roughness Ra is the arithmetic mean of the absolute values (without differentiation between peaks and valleys) of the heights of the profile length.

    Measured by 3D PRIMOS-CR SYSTEM

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  2. Rz parameter to evaluate smoothing/anti-wrinkle effect

    Rz= Average height of the roughness= Average relief Rz is the average of 5 single roughness depths, measured within the section ln. The single roughness depth is the difference from the highest profile peak to the deepest profile valley within a single measurement section.

    Measured by 3D PRIMOS-CR SYSTEM

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  3. Rt parameter to evaluate smoothing/anti-wrinkle effect

    Rt= Maximum height of the roughness profile= maximum relief amplitude Rt is the height difference from the highest peak to the deepest valley within the total measurement section Measured by 3D PRIMOS-CR SYSTEM

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  4. Clinical scoring of the visibility of crow's feet wrinkles

    Assessed by the investigator according to the BAZIN scale (7-point scale, from 0 to 6)

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  5. Clinical scoring of the Smoothness of the skin

    Assessed by the investigator on a 11-point scale (0 = rough skin, 10 = very smooth skin)

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  6. Clinical scoring of the Firmness of the skin

    Assessed by the investigator on a 11-point scale (0 = sagged skin, 10 = very firm skin)

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  7. Clinical scoring of the Skin plumpness

    Assessed by the investigator on a 11-point scale (0 = thin and not replumped skin, 10 = very replumped skin)

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  8. Clinical scoring of Radiance/ Luminosity based on photographs

    Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= dull, 10= radiant/luminous) based on photographs taken by Colorface

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  9. Clinical scoring of Skin brightness based on photographs

    Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not bright at all, 10= very bright) based on photographs taken by Colorface

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  10. Clinical scoring of homogeneity of skin tone based on photographs

    Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not even at all, 10= very even) based on photographs taken by Colorface

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

  11. Clinical scoring of homogeneity of skin texture based on photographs

    Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= coarse, 10= fine) based on photographs taken by Colorface

    Measured: Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).

Timeline

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

  1. First posted6 Oct 2025
  2. Study start27 Oct 2021
  3. Primary completion7 Feb 2022
  4. Study completion7 Feb 2022

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07208227
Sponsor's protocol ID
RV4983A20210135
Status last verified
Sep 2025
First submitted
15 Sep 2025
Last updated
6 Oct 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 Healthy and Sensitive Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

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

Who may be eligible to take part?

The sponsor lists 44 inclusion and 0 exclusion criteria. 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 6 Oct 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 Poland. 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?

Global tolerance assessment (time frame: At the end of the study, after Last Patient Out, (after Day 57)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07208227.

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 6 Oct 2025.

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