Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 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 (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin.
Timm*: 10 to 30 minutes after first application
his study is a national, monocentric, non-randomized open trial, conducted in adults presenting hypersensitive, reactive and intolerant skin on the face, with a dry to very dry 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 RV4942A - RY1985 with comparison of each time versus baseline.
There are twice-daily applications (morning and evening) of the test product on the face.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV4942A arm | RV4942A 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 | RV4942A is a face balm 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 |
Not provided
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:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lexi LIU | EUROFINS CHINA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins China | Guangzhou | Haizhu District | 510289 | China |
Not provided
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |