Clinical Study for the Efficacy Evaluation of a Food Supplement
- Conditions
- WrinkleSpot Pigmented
- Interventions
- Other: Placebo productOther: Mentha Suaveolens extract incorporated into a food supplement
- Registration Number
- NCT06453837
- Lead Sponsor
- Mibelle Group Biochemistry
- 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 supplement's 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 supplement's 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 whitening/brightening 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 (Courage+Khazaka 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 use/purchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28, 56 and 84 consecutive days of food supplement's 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 supplement's 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 supplement's 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 whitening/brightening 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 (Courage+Khazaka 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 use/purchase intention towards the food supplements by filling out a subjective evaluation questionnaire after 28, 56 and 84 consecutive days of food supplement's 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo product Placebo product The comparator product is a placebo (Ref.: S-1171a) with the same formulation as the investigational product, except for the active ingredient, on a 200ml bottle and each bottle have 50 capsules of food supplement, manufactured by Mibelle Biochemistry (Bolimattstr. 1, CH - 5033 Buchs). Each subject of this group takes 1 capsule of comparator product per day, with lunch, for 84 consecutive days. Active ingredient incorporated into a food supplement Mentha Suaveolens extract incorporated into a food supplement The investigational product (Ref.: S-1171b) is packed on a 200ml bottle and each bottle have 50 capsules of food supplement, manufactured by Mibelle Biochemistry (Bolimattstr. 1, CH - 5033 Buchs). Each subject of this group takes 1 capsule of the food supplement per day, with lunch, for 84 consecutive days.
- Primary Outcome Measures
Name Time Method Skin whitening/brightening evaluation From enrollment to the end of treatment: before (t0) and after 28 (t1), 56 (t2) and 84 (t3) consecutive days of food supplement's once-daily intake. The skin whitening/brightening is evaluated by measuring the L\*parameter, with the equipment Antera 3D before (t0) and after 28 (t1), 56 (t2) and 84 (t3) consecutive days of a once-daily intake, in comparison with the baseline and a placebo.
The skin whitening/brightening evaluation depigmenting translated in the L\* parameter represents lightness from black to white on a scale of 0 to 100. The higher the value of the L\* parameter, the lighter the skin colour, which represents a whitening effect.Skin depigmenting evaluation From enrollment to the end of treatment: before (t0) and after 28 (t1), 56 (t2) and 84 (t3) consecutive days of food supplement's once-daily intake. The skin depigmenting is evaluated by measuring the melanin variation parameter with the equipment Antera 3D before (t0) and after 28 (t1), 56 (t2) and 84 (t3) consecutive days of a once-daily intake, in comparison with the baseline and a placebo.
Variation of melanin provides information on the uniformity of the pigment. The variation is inversely proportional to the uniformity of the pigment, meaning that a lower melanin variation corresponds to a higher degree of uniformity, consequently a decrease on the melanin variation parameter means that the skin tone is more even.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inovapotek, Pharmaceutical Research And Development Lda
🇵🇹Porto, Portugal