Clinical Study for the Efficacy Evaluation of a Food Supplement

NCT06453837 | Completed

• 1 other identifier: CIP no. P016C23 (v01)
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Skin depigmenting evaluation

  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.

  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.

• Skin whitening/brightening evaluation

  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.

  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.

Other Outcomes (10)

• Skin colour and skin tone evenness 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.

• Skin density evaluation of the dermis

  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.

• Skin hydration 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.

Study Arms (2)

Active ingredient incorporated into a food supplement

EXPERIMENTAL

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.

Other: Mentha Suaveolens extract incorporated into a food supplement

Placebo product

PLACEBO COMPARATOR

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.

Other: Placebo product

Interventions

Mentha Suaveolens extract incorporated into a food supplement OTHER

Each subject of this group takes 1 capsule of the food supplement per day, with lunch, for 84 consecutive days.

Active ingredient incorporated into a food supplement

Placebo product OTHER

Each subject of this group takes 1 capsule of comparator product per day, with lunch, for 84 consecutive days.

Placebo product

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mibelle Group Biochemistry: lead
• Inovapotek, Pharmaceutical Research And Development Lda: collaborator

Study Sites (1)

Inovapotek, Pharmaceutical Research And Development Lda

Porto, 4200-135, Portugal

Location

MeSH Terms

Conditions

Exanthema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marta Ferreira

  Inovapotek, Pharmaceutical Research And Development Lda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigational and comparator products are alphabetically coded, using the codes A and B, by inovapotek's personnel not involved in the clinical study in order for the study to be performed in a double blinded fashion. Subjects and Investigators enrolled in this study will not know to what product each code corresponds. The traceability of the products during and after the clinical investigation will be achieved by assignment of a code number and a batch number to each product. 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: June 12, 2024
• Study Start: June 21, 2023
• Primary Completion: December 21, 2023
• Study Completion: March 8, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)