Clinical trial NCT06453837: Clinical Study for the Efficacy Evaluation of a Food Supplement
Official title: Double Blinded Randomized Placebo Controlled Clinical Study for the Evaluation of the Efficacy of One Active Ingredient Incorporated Into a Food Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spot Pigmented
Wrinkle
Keywords: Food Supplement
Apple mint extract
Skin spots
Depigmenting effect
Skin tone evenness
Skin whitening/brightening
Skin hydration
Skin firmness
Skin radiance
Lead sponsor: Mibelle Group Biochemistry
Sponsor class: INDUSTRY
Collaborators: name: Inovapotek, Pharmaceutical Research And Development Lda
First posted: 2024-06-12
Enrollment: 110
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects are randomly divided in two groups, the test group, taking the active ingredient (Mentha Suaveolens extract) incorporated into a food supplement and the placebo group, taking the food supplement without the active ingredient. Each subject is randomly assigned to one of the groups (Group I or Group II) according to a Table of Random Numbers created on Microsoft Office Excel.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria for Group I/II:

* Gender: Female;
* Age: between 25 and 60 years old;
* Having signed an Informed Consent Form (ICF);
* Willingness, ability and likeliness to comply with all the study procedures and restrictions;
* Available during the entire study period;
* Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents;
* Presenting skin phototype between III to V according to the Fitzpatrick phototyping scale;
* Presenting mild to moderate fine lines and wrinkles on the crow's feet area on at least one side of the face;
* Presenting mild to moderate skin spots on the forehead and/or cheek of at least one side of the face;
* Presenting self-perceived normal do dry skin type;
* Having a stable means of contraception for at least 3 months before beginning of the study and not changing the means of contraception during the study;
* Willing to not use any other products/treatments/home remedies except the provided products and their normal make-up and cleansing products during the study;
* Willing to not expose excessively to sunlight (sun exposure not more than one hour daily and during that time use of umbrella to cover face), and to not attend artificial sun beds during the study;
* Willingness to apply sunscreen 15-30 minutes before sun exposure and to record its use in the daily log;

Exclusion criteria for Group I/II:

* Known allergy or known history of hypersensitivity to the components of the investigational and comparative products (e.g. mint-based products), to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else;
* Currently participating in a clinical study that may interfere with the present study or having participated in a clinical study with face products or food supplements for less than 1 month before the beginning the study;
* Having any history of significant, acute, or chronic dermatological conditions or diseases (e.g. eczema, psoriasis, sclerosis, acne condition, skin allergies etc.);
* Having any history of systemic diseases or even infections (e.g. diabetes, hypertension, cardiovascular, upper respiratory infections, urinary tract infections etc.);
* Presenting signs or symptoms of irritated or damaged facial skin (any skin area which shows any desquamation, severe dryness, skin picking, etc.);
* Having performed major anti-ageing, anti-wrinkles, rejuvenating, whitening, depigmenting and smoothing treatments on the 30 days preceding the beginning of the study (including but not limited to: topical hydroquinone, topical treatments with benzoyl peroxide, retinoid, face lifts, cryotherapy, injectable fillers, electrosurgery, CO2 laser, peelings, laser or intense pulsed light) or with intention to perform it during the study;
* Having performed pharmacological treatments systemic/topical on the 30 days before the beginning of the study or currently taking medication that may impair the study;
* Having changed the usual daily cosmetic products (including cleansing and make-up products) and/or habits in the face on the 15 days preceding the beginning of the study;
* Intention of prolonged solar exposure or going to tanning beds on the 15 days preceding the beginning of the study and/or during the course of the study
* Having an activity-based outdoor occupation or with hobbies requiring excessive sun exposure;
* Smokers or users of tobacco products, including vaping products;
* Having history of heavy caffeine consumption of ≥ 4 cups in a day;
* Having high-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week.
* Pregnancy or intention to conceive during the study;
* Breast-feeding.

Primary outcomes:
measure: Skin depigmenting evaluation
timeFrame: 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.
measure: Skin whitening/brightening evaluation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Skin colour and skin tone evenness evaluation
timeFrame: 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.
measure: Skin density evaluation of the dermis
timeFrame: 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.
measure: Skin hydration evaluation
timeFrame: 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.
measure: Skin firmness evaluation
timeFrame: 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.
measure: Skin overall elasticity evaluation
timeFrame: 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.
measure: Skin total deformation evaluation
timeFrame: 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.
measure: Clinical evaluation of skin radiance
timeFrame: 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.
measure: Subjective evaluation questionnaire
timeFrame: From enrollment to the end of treatment: after 28 (t1), 56 (t2) and 84 (t3) consecutive days of food supplement's once-daily intake.
measure: Daily Log Questionnaire Analysis
timeFrame: From enrollment to the end of treatment: sence day 1 (t0) to 84 (t3) consecutive days of food supplement's once-daily intake.
measure: Photographs
timeFrame: 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.
Locations:
city: Porto
country: Portugal
facility: Inovapotek, Pharmaceutical Research And Development Lda
Study officials:
affiliation: Inovapotek, Pharmaceutical Research And Development Lda
name: Marta Ferreira
role: PRINCIPAL_INVESTIGATOR
References: