Status:
COMPLETED
In-use Tolerance and Efficacy Study Under Dermatological and Ophthalmological Controls - Face Cream, RV4983A - LA3365
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Healthy
Sensitive Skin
Eligibility:
FEMALE
45-65 years
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-randomiz...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07208227
Start Date
October 27 2021
End Date
February 7 2022
Last Update
October 6 2025
Active Locations (1)
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1
Eurofins Dermscan Poland Sp. z o. o
Gdansk, Poland, Poland, 80288