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

IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT

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

Study Overview

• Status: Completed
• Conditions: Hypersensitive; Reactive and Intolerant Skin; Redness-prone Skin; Stinger Subjects
• Intervention / Treatment: Other: Cosmetic product

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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• China
  • Haizhu District
    • Guangzhou, Haizhu District, China, 510289
      • Eurofins Consumer Product Testing (Guangzhou) Co. Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RV4941A arm; RV4941A study product is applied twice a day (morning and evening) on the face, neck and eye contour during the whole study.	Other: Cosmetic product; RV4941A is a face cream product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global tolerance assessment of the investigational product by dermatological evaluation	Dermatological evaluation based on physical and functional signs assessment by the dermatologist	Change from baseline to just after application and to 3 weeks later
Global tolerance assessment of the investigational product by ophthalmological evaluation	Ophthalmological evaluation based on physical and functional signs assessment by the ophthalmologist	Change from baseline to just after application and to 3 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous sensitivity by stinging test	Stinging test is an in vivo methodology that evaluates sensitive skin and consists in application of 10% lactic acid on one nasolabial fold of subject's nasogenian folds.	Change from baseline to 3 weeks later
Cutaneous sensitivity by sensitivity scale questionnaire	Subjects assess the degree of their overall face skin irritation using an Analogue Visual Scale and fill out the sensitivity scale questionnaire regarding physical and functional cutaneous signs to score from 0 to 10.	Change from baseline to 1 week and to 3 weeks later
Soothing efficacy by a questionnaire	Subjects evaluate the soothing effect of the investigational product with a questionnaire.	Change from just after application to 1 week and to 3 weeks later
Cosmetic acceptability and efficacy perceived questionnaire	Questionnaire with open questions and scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one.	After 3 weeks of tested product

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Study Chair: Lexi LIU, Eurofins China

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Hypersensitive skin; Discomfort sensations; Asian skin; Sensitivity reduction
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: RV4941A20200165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No