Clinical trial NCT05165420: IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Cream)
Official title: IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitive
Reactive and Intolerant Skin
Redness-prone Skin
Stinger Subjects
Keywords: Hypersensitive skin
Discomfort sensations
Asian skin
Sensitivity reduction
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects have been recruited from the panel of the centre. An investigator made a dermatological examination of the subjects before inscription in the panel. Data from this clinical examination, stored in the computer database with the consent of the subjects, can ensure the recruitment; computer software being questioned based on the eligibility criteria of the study.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Global tolerance assessment of the investigational product by dermatological evaluation
timeFrame: Change from baseline to just after application and to 3 weeks later
measure: Global tolerance assessment of the investigational product by ophthalmological evaluation
timeFrame: Change from baseline to just after application and to 3 weeks later
Secondary outcomes:
measure: Cutaneous sensitivity by stinging test
timeFrame: Change from baseline to 3 weeks later
measure: Cutaneous sensitivity by sensitivity scale questionnaire
timeFrame: Change from baseline to 1 week and to 3 weeks later
measure: Soothing efficacy by a questionnaire
timeFrame: Change from just after application to 1 week and to 3 weeks later
measure: Cosmetic acceptability and efficacy perceived questionnaire
timeFrame: After 3 weeks of tested product
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Eurofins Consumer Product Testing (Guangzhou) Co. Ltd
state: Haizhu District
Study officials:
affiliation: EUROFINS CHINA
name: Lexi LIU
role: STUDY_CHAIR
References: