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

NCT ID: NCT07208227

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2022-02-07

Brief 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.

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.

Conditions

Healthy; Sensitive Skin; Deep Wrinkles

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Test group

Face Cream RV4983A LA3365

Intervention Type: OTHER

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

Interventions

Face Cream RV4983A LA3365

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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
• 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

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Dermscan Poland Sp. z o. o

Gdansk, Poland, Poland

Countries

Poland

Other Identifiers

RV4983A20210135

Identifier Type: -

Identifier Source: org_study_id