Spot PigmentedNCT06453837
Clinical Study for the Efficacy Evaluation of a Food Supplement
A study testing Mentha Suaveolens extract incorporated into a food supplement in people with Spot Pigmented and Wrinkle, run by Mibelle Group Biochemistry at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Spot Pigmented, Wrinkle
- What is being tested?
- Mentha Suaveolens extract incorporated into a food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 21 Jun 2023to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Inovapotek, Pharmaceutical Research And Development Lda
Porto, 4200-135
About this study
Official title: Double Blinded Randomized Placebo Controlled Clinical Study for the Evaluation of the Efficacy of One Active Ingredient Incorporated Into a Food Supplement
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.
Read more
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.
Read the 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.
- Conditions
- Spot Pigmented, Wrinkle
- Being tested
- Mentha Suaveolens extract incorporated into a food supplement, Placebo product
- Keywords
- Food Supplement, Apple mint extract, Skin spots, Depigmenting effect, Skin tone evenness, Skin whitening/brightening, Skin hydration, Skin firmness, Skin radiance
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentha Suaveolens extract incorporated into a food supplementOther
Each subject of this group takes 1 capsule of the food supplement per day, with lunch, for 84 consecutive days.
Placebo productOther
Each subject of this group takes 1 capsule of comparator product per day, with lunch, for 84 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start21 Jun 2023
- Primary completion21 Dec 2023
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spot PigmentedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mibelle Group Biochemistry
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inovapotek, Pharmaceutical Research And Development Lda
- Responsible party
- Sponsor
- Investigators
- Marta Ferreira, Principal investigator, Inovapotek, Pharmaceutical Research And Development Lda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453837
- Sponsor's protocol ID
- CIP no. P016C23 (v01)
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be published in a scientific journal and it is therefore preferable not to give access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Placebo Controlled Clinical Study for the Evaluation of the Efficacy of One Active Ingredient Incorporated Into a Food Supplement
- ClinicalTrials.gov ID
- NCT06453837
- Acronym / sponsor ID
- CIP no. P016C23 (v01)
- Conditions
- Spot Pigmented, Wrinkle
- Keywords
- Food Supplement, Apple mint extract, Skin spots, Depigmenting effect, Skin tone evenness, Skin whitening/brightening, Skin hydration, Skin firmness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mibelle Group BiochemistryIndustry (pharma, biotech, devices)
- Collaborators
- Inovapotek, Pharmaceutical Research And Development Lda
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active ingredient incorporated into a food supplement | Experimental | Other: Mentha Suaveolens extract incorporated into a food supplementThe 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. |
| Placebo product | Placebo comparator | Other: Placebo productThe 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (15 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentha Suaveolens extract incorporated into a food supplementEach subject of this group takes 1 capsule of the food supplement per day, with lunch, for 84 consecutive days. | Other | Active ingredient incorporated into a food supplement |
| Placebo productEach subject of this group takes 1 capsule of comparator product per day, with lunch, for 84 consecutive days. | Other | Placebo product |
Primary outcome
Skin depigmenting evaluation
Time frame: 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.
Skin whitening/brightening evaluation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No. The results will be published in a scientific journal and it is therefore preferable not to give access to the data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Ferreira principal investigator
Inovapotek, Pharmaceutical Research And Development Lda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentha Suaveolens extract incorporated into a food supplement in people with Spot Pigmented and Wrinkle, run by Mibelle Group Biochemistry at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin depigmenting evaluation (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.