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The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.
First study phase (soothing activity)
Clinical grading (visual analogic scale):
Optical colorimetry: measurement of redness/bruise (L*a*b*) by Spectrophotometer CM-2600d.
Photographic documentation: Canfield imaging station equipped with visible, polarized, fluorescence and UV light and with specific lighting for shadows.
Second study phase (anti-age activity vs placebo):
Clinical and self grading (visual analogic scale) :
Optical colorimetry: measurement of skin colour (L*a*b*) by Spectrophotometer CM-2600d.
Photographic documentation: Canfield imaging station equipped with visible, polarized, fluorescence and UV light and with specific lighting for shadows.
Skin replicas and profilometry at level of crow's feet (image analysis of: total surface of the wrinkles, mean length of the wrinkles, total length of the wrinkles, number of the wrinkles)
Skin elasticity measurement by suction (Cutometer®)
Tolerance evaluation (investigator's judgement):
At each evaluation time, the investigator considering the appearance of possible adverse effects related to the tested creams and all comments reported by the subjects on diary card will judge the tolerance of the products under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin aging | Experimental | Anti-age product will be applied once a day, in the evening, on half face and neck for an uninterrupted period of 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (right or left side according to a previous randomisation list), the volunteers will apply the placebo cream twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds | For 7 days after injections (from T0 to T7d/T0'') the soothing cream will be applied twice a day on the full face and neck insisting on injection areas. 5 visits will be performed: a pre-test visit (T-30 subjects' screening), a baseline visit (T0 intradermal implant execution/ T0' evaluations just after the aesthetic procedure/ Timm evaluations immediately after the 1st soothing cream application), 2 intermediate visits (T1d, T3d - 1 and 3 days after injections) and a final visit (T7d - 7 days after the aesthetic procedure). Product tolerance (number of participants with adverse events) and efficacy:
| 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream to identify additional benefits delivered by the product compared to a cosmetic procedure | The anti-age product will be applied once a day, in the evening, on half face and neck, for 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (according to a previous randomisation list), the volunteers will apply the placebo cream twice a day. 5 visits will be performed: a baseline visit (T0 - before aesthetic procedure), a visit 7 days after injection (T0''/T7d), 2 intermediate visits (T4W and T8W - 4 and 8 weeks after the first study product application) and a final visit (T12W - 12 weeks after the first study product application). Tolerance (number of participants with adverse events) and efficacy:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ADELE SPARAVIGNA, PHYSICIAN | Derming SRL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING | Monza | Monza-brianza | 20900 | Italy |
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| 3 months |