Skin Aging Clinical Trial
Official title:
Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid (Intradermal Implant)
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):
1. Erythema (0= no erythema to 10= strong erythema)
2. Oedema (0= no oedema to 10= strong oedema)
3. Bruise (0= no bruise to 10= strong bruise)
4. Overall skin appearance (0= bad overall appearance to 10= good overall
appearance).
- 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) :
1. Forehead wrinkles (0= no wrinkle to 10= severe wrinkles)
2. Crow's feet wrinkles (0= no wrinkle to 10= severe wrinkles)
3. Crow's feet fine lines (0= no fine line to 10= severe fine lines)
4. Under the eye wrinkles (0= no wrinkle to 10= severe wrinkles)
5. Under the eye fine lines (0= no fine line to 10= severe fine lines)
6. Frown lines (0= no wrinkle to 10= severe wrinkles)
7. Marionette lines (0= no wrinkle to 10= severe wrinkles)
8. Upper lip wrinkles (0= no wrinkle to 10= severe wrinkles)
9. Nasolabial folds (0= no wrinkle to 10= severe wrinkles)
10. Cheek wrinkles (0= no wrinkle to 10= severe wrinkles)
11. Neck wrinkles (0= no wrinkle to 10= severe wrinkles)
12. Lines on the neck opening (0= no wrinkle to 10= severe wrinkles)
13. Skin firmness (0= very firm skin to 10= no firm skin)
14. Skin elasticity (0= very elastic skin to 10= no elastic skin)
15. Sagging skin (0= no sagging skin to 10= severe sagging skin)
16. Radiance (0= very radiant skin to 10= no radiant skin)
17. Smoothness (0= very smooth skin to 10= no smooth skin)
18. Skin softness (0= very soft skin to 10= no soft skin)
19. Colour evenness (0= good evenness to 10= bad evenness)
20. Skin tone (0= good complexion to 10= bad complexion)
- 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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