Ignite Creation Date:
2024-05-06 @ 3:05 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02204436
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2014-07-18
Brief Title:
Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
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:
None
Brief Summary:
Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a cosmetic treatment for spotted hand skin in particular it was investigated the synergic activity of an emulsion with clarifying-antioxidant activity combined with an activator gel with hydration and keratolytic activity
Female healthy volunteers aged 45-65 years old presenting senile lentigo on the hands were included in the study
It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers
Female healthy volunteers aged 45-65 years old presenting senile lentigo on the hands were included in the study
It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers
Detailed Description:
The following instrumental evaluations were performed in basal conditions T0 - before product use after 4 T4 and 8 week-treatment T8
Image analysis with UV flash Woods light
Photographic recovery
Skin spots image analysis
Skin colour evaluation
Spectrophotometry skin brightness
Optical colorimetry spots colour
At the end of the study T8 each volunteer filled a questionnaire regarding
the efficacy of the study product skin brightness and hydration spots dimensions and colour intensity - score very marked marked medium light absent
the cosmetic acceptability of the study product colour and perfume before and after application consistency spreadability absorption effect on the skin greasiness and presence of product residues score negative medium good excellent the product tolerance score bad poor medium good excellent
At the end of the study the investigator assessed the treatment tolerance considering the possible appearance of related adverse events as bad poor medium good excellent
Image analysis with UV flash Woods light
Photographic recovery
Skin spots image analysis
Skin colour evaluation
Spectrophotometry skin brightness
Optical colorimetry spots colour
At the end of the study T8 each volunteer filled a questionnaire regarding
the efficacy of the study product skin brightness and hydration spots dimensions and colour intensity - score very marked marked medium light absent
the cosmetic acceptability of the study product colour and perfume before and after application consistency spreadability absorption effect on the skin greasiness and presence of product residues score negative medium good excellent the product tolerance score bad poor medium good excellent
At the end of the study the investigator assessed the treatment tolerance considering the possible appearance of related adverse events as bad poor medium good excellent
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