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

Pierre Fabre

Status: Completed

Conditions: Redness-prone Skin; Stinger Subjects; Hypersensitive; Reactive and Intolerant Skin

Treatments: Other: Cosmetic product

Study type: Observational

Funder types: Industry

Identifiers

NCT05165420

RV4941A20200165

Details and patient eligibility

About

The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Crème visage / Face cream RV4941A - RY1987 after 21 days of twice daily use on the study areas, under normal conditions of use.

The aim of this study is also to:

• evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.
• evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm*, D8 and D22.
• evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm*, D8 and D22.
• evaluate the cosmetic acceptability by a questionnaire at D22.

This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a normal to combination skin.

Timm*: 10 to 30 minutes after first application

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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

2. 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

1. 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

2. 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)

Trial design

33 participants in 1 patient group

RV4941A arm

Description:

RV4941A study product is applied twice a day (morning and evening) on the face, neck and eye contour during the whole study.

Treatment:

Other: Cosmetic product