Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453837
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-01-23
Brief Title:
Clinical Study for the Efficacy Evaluation of a Food Supplement
Sponsor:
Mibelle Group Biochemistry
Organization:
Mibelle Group Biochemistry
Study Overview
Official Title:
Double Blinded Randomized Placebo Controlled Clinical Study for the Evaluation of the Efficacy of One Active Ingredient Incorporated Into a Food Supplement
Status:
COMPLETED
Status Verified Date:
2024-06
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 primary aim of this in vivo clinical study is to evaluate the depigmenting effect of an active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 28 consecutive days of food supplements once-daily intake in comparison with the baseline and a placebo
The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 56 and 84 consecutive days of food supplements once-daily intake
Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement after 28 56 and 84 consecutive days of a once-daily intake in comparison with the baseline and a placebo 1 on skin whiteningbrightening through the evaluation of the L parameter assessed with the equipment Antera 3D Miravex Ireland 2 on the skin colour homogeneity through the measurement of the ITAº Individual Typology Angle parameter assessed with the equipment Colorimeter CL400 3 on the skin tone evenness through the measurement of the standard deviation of the skin colour assessed with the equipment Colorimeter CL400 4 on the skin density of the dermis measured with the equipment Episcan 35 MHz Longport Inc United States 5 on skin hydration assessed through capacitance measurements with the equipment Corneometer CM825 6 on the skin firmness skin overall elasticity and skin total deformation measured with the equipment Cutometer SEM 575 CourageKhazaka electronic GmbH Germany and 7 on skin radiance through clinical evaluation performed by an expert
It is also objective of this clinical study to evaluate 8 subjects tolerance acceptability perception of efficacy and future usepurchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28 56 and 84 consecutive days of food supplements once-daily intake
The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 56 and 84 consecutive days of food supplements once-daily intake
Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement after 28 56 and 84 consecutive days of a once-daily intake in comparison with the baseline and a placebo 1 on skin whiteningbrightening through the evaluation of the L parameter assessed with the equipment Antera 3D Miravex Ireland 2 on the skin colour homogeneity through the measurement of the ITAº Individual Typology Angle parameter assessed with the equipment Colorimeter CL400 3 on the skin tone evenness through the measurement of the standard deviation of the skin colour assessed with the equipment Colorimeter CL400 4 on the skin density of the dermis measured with the equipment Episcan 35 MHz Longport Inc United States 5 on skin hydration assessed through capacitance measurements with the equipment Corneometer CM825 6 on the skin firmness skin overall elasticity and skin total deformation measured with the equipment Cutometer SEM 575 CourageKhazaka electronic GmbH Germany and 7 on skin radiance through clinical evaluation performed by an expert
It is also objective of this clinical study to evaluate 8 subjects tolerance acceptability perception of efficacy and future usepurchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28 56 and 84 consecutive days of food supplements once-daily intake
Detailed Description:
The primary aim of this in vivo clinical study is to evaluate the depigmenting effect of an active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 28 consecutive days of food supplements once-daily intake in comparison with the baseline and a placebo
The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 56 and 84 consecutive days of food supplements once-daily intake
Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement after 28 56 and 84 consecutive days of a once-daily intake in comparison with the baseline and a placebo 1 on skin whiteningbrightening through the evaluation of the L parameter assessed with the equipment Antera 3D Miravex Ireland 2 on the skin colour homogeneity through the measurement of the ITAº Individual Typology Angle parameter assessed with the equipment Colorimeter CL400 3 on the skin tone evenness through the measurement of the standard deviation of the skin colour assessed with the equipment Colorimeter CL400 4 on the skin density of the dermis measured with the equipment Episcan 35 MHz Longport Inc United States 5 on skin hydration assessed through capacitance measurements with the equipment Corneometer CM825 6 on the skin firmness skin overall elasticity and skin total deformation measured with the equipment Cutometer SEM 575 CourageKhazaka electronic GmbH Germany and 7 on skin radiance through clinical evaluation performed by an expert
It is also objective of this clinical study to evaluate 8 subjects tolerance acceptability perception of efficacy and future usepurchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28 56 and 84 consecutive days of food supplements once-daily intake
In order to perform this study 110 female healthy subjects with ages between 25 and 60 years old presenting mild to moderate fine lines and wrinkles mild to moderate skin spots and phototype III to V according to the Fitzpatrick phototyping scale are enrolled The subjects are randomly divided in two groups the test group taking the active ingredient incorporated into a food supplement and the placebo group taking the food supplement without the active ingredient
A 2 weeks washout period is performed if subject has taken any kind of supplements Vitamins antioxidants nutraceuticals before the beginning of the study In this period subjects cannot use any kind of supplements
Each subject shall take 1 capsule of the food supplement per day with lunch for 84 consecutive days
The secondary objective of this study is to evaluate in vivo the depigmenting effect of the same active ingredient incorporated into a food supplement through the evaluation of the melanin variation parameter assessed with the equipment Antera 3D Miravex Ireland after 56 and 84 consecutive days of food supplements once-daily intake
Other goals of this clinical study are to evaluate in vivo the effect of the same active ingredient incorporated into a food supplement after 28 56 and 84 consecutive days of a once-daily intake in comparison with the baseline and a placebo 1 on skin whiteningbrightening through the evaluation of the L parameter assessed with the equipment Antera 3D Miravex Ireland 2 on the skin colour homogeneity through the measurement of the ITAº Individual Typology Angle parameter assessed with the equipment Colorimeter CL400 3 on the skin tone evenness through the measurement of the standard deviation of the skin colour assessed with the equipment Colorimeter CL400 4 on the skin density of the dermis measured with the equipment Episcan 35 MHz Longport Inc United States 5 on skin hydration assessed through capacitance measurements with the equipment Corneometer CM825 6 on the skin firmness skin overall elasticity and skin total deformation measured with the equipment Cutometer SEM 575 CourageKhazaka electronic GmbH Germany and 7 on skin radiance through clinical evaluation performed by an expert
It is also objective of this clinical study to evaluate 8 subjects tolerance acceptability perception of efficacy and future usepurchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28 56 and 84 consecutive days of food supplements once-daily intake
In order to perform this study 110 female healthy subjects with ages between 25 and 60 years old presenting mild to moderate fine lines and wrinkles mild to moderate skin spots and phototype III to V according to the Fitzpatrick phototyping scale are enrolled The subjects are randomly divided in two groups the test group taking the active ingredient incorporated into a food supplement and the placebo group taking the food supplement without the active ingredient
A 2 weeks washout period is performed if subject has taken any kind of supplements Vitamins antioxidants nutraceuticals before the beginning of the study In this period subjects cannot use any kind of supplements
Each subject shall take 1 capsule of the food supplement per day with lunch for 84 consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None