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

NCT05165420 | Completed

• 1 other identifier: RV4941A20200165
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Hypersensitive skin; Discomfort sensations; Asian skin; Sensitivity reduction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Cutaneous sensitivity by stinging test

  Change from baseline to 3 weeks later

• Cutaneous sensitivity by sensitivity scale questionnaire

  Change from baseline to 1 week and to 3 weeks later

• Soothing efficacy by a questionnaire

  Change from just after application to 1 week and to 3 weeks later

• Cosmetic acceptability and efficacy perceived questionnaire

  After 3 weeks of tested product

Study Arms (1)

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

Interventions

Cosmetic product OTHER

RV4941A is a face cream product

RV4941A arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Eurofins Consumer Product Testing (Guangzhou) Co. Ltd

Guangzhou, Haizhu District, 510289, China

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Lexi LIU

  EUROFINS CHINA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: March 17, 2021
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

CN (1)