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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:
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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV4941A arm | RV4941A study product is applied twice a day (morning and evening) on the face, neck and eye contour during the whole study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product | Other | RV4941A is a face cream product |
|
| 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 |
| 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 |
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Inclusion Criteria:
Criteria related to the population:
Criteria related to diseases and general health:
Exclusion Criteria:
Criteria related to the population:
Criteria related to investigational product application areas:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lexi LIU | EUROFINS CHINA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Consumer Product Testing (Guangzhou) Co. Ltd | Guangzhou | Haizhu District | 510289 | China |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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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 |