Ignite Creation Date:
2024-05-05 @ 9:49 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00975728
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-09-10
Brief Title:
High Total Antioxidant Capacity Products Added to Diet
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
High Total Antioxidant Capacity TAC Products Added to Diet Clinical and Instrumental Evaluation of Their Effect on Skin Surface Parameters and on Photo-induced Acute Damage of the Skin Double Blind Clinical Study vs Placebo
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties
Detailed Description:
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed
1 Evaluation of experimentally induced erythema inhibition in basal conditions before starting the assumption of the test productplacebo and at T4 T8 T12 T16 weeks each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR ultraviolet radiations mJcm2 in order to determine the MED minimal erythema dose of unprotected skin 20-4 hours after the UV exposure clinical and instrumental optical densitometry evaluations of skin erythema and photographic documentation only on 16 preselected cases will be performed
2 Blood samples collection for the determination of the principal antioxidants concentration for example lutein carotene lycopene and E vitamin at T0 T4 T8 and T12 blood samples 5 ml of venous blood will be collected on each volunteer by the Medical Staff The samples will be sent to an external laboratory for haematologic control task
To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed
1 Non Invasive instrumental evaluation of principal skin parameters epicutaneous pH skin hydration skin electrical capacitance skin firmness plastoelasticity skin texture skin surface irregularity index - FFT on skin replicas measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third left or right side according to a previously defined randomization list
2 Clinical pictures with UV flash Woods light at T0 and T8 20 preselected cases of fairy skinned volunteers selected on the basis of clinical ananmnesis regarding photosensitivity will be submitted to the realization of clinical pictures at the level of the face using a special UV flash able to highlight melanin spots even if not yet visible at the naked eye
Moreover aim of the study is also to evaluate the best dosage of the beverage 1 or 2 servings of 250 mla day
1 Evaluation of experimentally induced erythema inhibition in basal conditions before starting the assumption of the test productplacebo and at T4 T8 T12 T16 weeks each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR ultraviolet radiations mJcm2 in order to determine the MED minimal erythema dose of unprotected skin 20-4 hours after the UV exposure clinical and instrumental optical densitometry evaluations of skin erythema and photographic documentation only on 16 preselected cases will be performed
2 Blood samples collection for the determination of the principal antioxidants concentration for example lutein carotene lycopene and E vitamin at T0 T4 T8 and T12 blood samples 5 ml of venous blood will be collected on each volunteer by the Medical Staff The samples will be sent to an external laboratory for haematologic control task
To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed
1 Non Invasive instrumental evaluation of principal skin parameters epicutaneous pH skin hydration skin electrical capacitance skin firmness plastoelasticity skin texture skin surface irregularity index - FFT on skin replicas measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third left or right side according to a previously defined randomization list
2 Clinical pictures with UV flash Woods light at T0 and T8 20 preselected cases of fairy skinned volunteers selected on the basis of clinical ananmnesis regarding photosensitivity will be submitted to the realization of clinical pictures at the level of the face using a special UV flash able to highlight melanin spots even if not yet visible at the naked eye
Moreover aim of the study is also to evaluate the best dosage of the beverage 1 or 2 servings of 250 mla day
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