Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02063971
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-02-07
Brief Title:
Tolerance and Efficacy Evaluation of 3 Face Creams
Sponsor:
Adele Sparavigna
Organization:
Derming SRL
Study Overview
Official Title:
Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid Intradermal Implant
Status:
UNKNOWN
Status Verified Date:
2014-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FILLER
Brief Summary:
The study will evaluate the tolerance and the efficacy on skin comfort of F1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F841-020 anti-age cream on aging parameters compared to baseline and to the F1374-002 placebo cream comparison within subjects - half face method to identify additional benefits delivered by the product compared to a cosmetic procedure
Detailed Description:
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 rednessbruise Lab 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 Crows feet wrinkles 0 no wrinkle to 10 severe wrinkles
3 Crows 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 Lab 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 crows 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 investigators 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
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 rednessbruise Lab 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 Crows feet wrinkles 0 no wrinkle to 10 severe wrinkles
3 Crows 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 Lab 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 crows 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 investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None