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Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial.
Planning of the visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face Cream RV4983A LA3365 | Other | Cosmetic face cream product applied once a day on face, neck and neckline. |
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| Measure | Description | Time Frame |
|---|---|---|
| Global tolerance assessment | Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. Global assessment of the dermatological and ophthalmological tolerance is done by the investigator. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad. | At the end of the study, after Last Patient Out, (after Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| Ra parameter to evaluate smoothing/anti-wrinkle effect | Ra= Average roughness Ra is the arithmetic mean of the absolute values (without differentiation between peaks and valleys) of the heights of the profile length. Measured by 3D PRIMOS-CR SYSTEM | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
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INCLUSION CRITERIA
Criteria related to the population:
Criteria related to subject's health:
NON INCLUSION CRITERIA
Criteria related to the population:
Criteria related to subject's health:
Criteria related to investigational product application areas:
Criteria related to the COVID-19 pandemic:
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Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study. They will be definitely included in the study after a specific interview and a clinical examination.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland Sp. z o. o | Gdansk | Poland | 80288 | Poland |
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| Rz parameter to evaluate smoothing/anti-wrinkle effect | Rz= Average height of the roughness= Average relief Rz is the average of 5 single roughness depths, measured within the section ln. The single roughness depth is the difference from the highest profile peak to the deepest profile valley within a single measurement section. Measured by 3D PRIMOS-CR SYSTEM | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Rt parameter to evaluate smoothing/anti-wrinkle effect | Rt= Maximum height of the roughness profile= maximum relief amplitude Rt is the height difference from the highest peak to the deepest valley within the total measurement section Measured by 3D PRIMOS-CR SYSTEM | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of the visibility of crow's feet wrinkles | Assessed by the investigator according to the BAZIN scale (7-point scale, from 0 to 6) | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of the Smoothness of the skin | Assessed by the investigator on a 11-point scale (0 = rough skin, 10 = very smooth skin) | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of the Firmness of the skin | Assessed by the investigator on a 11-point scale (0 = sagged skin, 10 = very firm skin) | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of the Skin plumpness | Assessed by the investigator on a 11-point scale (0 = thin and not replumped skin, 10 = very replumped skin) | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of Radiance/ Luminosity based on photographs | Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= dull, 10= radiant/luminous) based on photographs taken by Colorface | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of Skin brightness based on photographs | Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not bright at all, 10= very bright) based on photographs taken by Colorface | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of homogeneity of skin tone based on photographs | Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= not even at all, 10= very even) based on photographs taken by Colorface | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |
| Clinical scoring of homogeneity of skin texture based on photographs | Assessed by three jury assessors who assess the parameter on unstructured scales (corresponding to scores from 0 to 10, 0= coarse, 10= fine) based on photographs taken by Colorface | Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57). |