IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Cream)
NCT05165420 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33
Last updated 2021-12-21
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
Interventions
- OTHER
-
Cosmetic product
RV4941A is a face cream product
Sponsors & Collaborators
-
Pierre Fabre Dermo Cosmetique
lead INDUSTRY
Principal Investigators
-
Lexi LIU · EUROFINS CHINA
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-17
- Primary Completion
- 2021-04-07
- Completion
- 2021-04-07
Countries
- China
Study Locations
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