An interventional study of Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) in Skin Aging, sponsored by Adele Sparavigna. Status unknown at 1 site in Italy. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-17.
Sponsored by Adele Sparavigna · Not applicable, Interventional, and Treatment
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):
Second study phase (anti-age activity vs placebo):
Clinical and self grading (visual analogic scale) :
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.
This is the only study on the registry with Adele Sparavigna as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)
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: * clinical and self grading (performed on injection areas by VAS score) * optical colorimetry (on nasolabial folds - L\*a\*b\*) * photographic documentation (of all the face) will be performed at each study time.
Time frame: 1 week
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: * clinical and self grading on face and neck (by VAS score) * optical colorimetry on both cheeks (L\*a\*b\*) * photographic documentation of all the face * skin elasticity on both cheeks (deformation-mm) * wrinkles profilometry on the lateral corner of the eyes (micron) will be evaluated at each study time.
Time frame: 3 months
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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