IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Cream)

This study is a national, monocentric, non-randomized open trial, conducted in adults presenting hypersensitive, reactive and intolerant skin on the face, with a normal to combination skin.

The study includes 3 visits, including subjects' selection:

• V1: Baseline inclusion
• V2: 1 week, intermediate visit
• V3: 3 weeks, study end

The maximal study duration is 25 days.

The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of RV4941A - RY1987 with comparison of each time versus baseline.

There are twice-daily applications (morning and evening) of the test product on the face.

Inclusion criteria

• Criteria related to the population:

• Male or Female aged between 18 and 65 years included
• Asian population (Chinese origin)
• Normal to combination skin on the face
• Subject with phototype I to IV included
• Subject having signed his/her written informed consent for his/her participation in the study
• Subject who is currently not participating in another clinical study
• Subject affiliated to a social security system or health insurance, or is a beneficiary
• For woman of childbearing potential: use of an effective method of contraception and using it during the whole duration of the study
• Criteria related to diseases and general health:

• Stinger subjects (evaluated by a stinger test)
• Subject with hypersensitive, reactive and intolerant skin on face
• Subject having a score superior to 4 on a sensitive scale for tightness parameter on the face
• Subject having a score superior to 4 on a sensitive scale for general discomfort parameter on the face

Exclusion criteria

• Criteria related to the population:

• For woman of childbearing potential: subject pregnant or breastfeeding or planning to be pregnant during the study
• 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 or incompatible with the study requirements
• 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
• Subject who is not likely to be compliant with study-related requirements
• Subject deprived of freedom by administrative or legal decision or under guardianship
• 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 2 weeks before the inclusion visit (at Investigator's opinion)