Tolerance and Efficacy Evaluation of 3 Face Creams (FILLER)
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|ClinicalTrials.gov Identifier: NCT02063971|
Recruitment Status : Unknown
Verified February 2014 by Adele Sparavigna, Derming SRL.
Recruitment status was: Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : February 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging||Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid (Intradermal Implant)|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
Experimental: Skin aging
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 [ Time Frame: 1 week ]
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.
- 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 [ Time Frame: 3 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063971
|Monza, Monza-brianza, Italy, 20900|
|Principal Investigator:||ADELE SPARAVIGNA, PHYSICIAN||Derming SRL|