Whitening efficacy of a food supplement
- Conditions
- Presence of skin spots related to age, sun exposure or post-inflammatory hyperpigmentationSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN12882379
- Lead Sponsor
- ROELMI HPC Srl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 66
1. Healthy female and male subjects
2. Age between 25 and 65 (extremes included) years old
3. Multi-ethnic panel
4. Subjects showing skin spots related to age, sun exposure or post-inflammatory hyperpigmentation
5. Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
6. Willingness to not use during the study period products other than the test product
7. Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers will list their usual routine: sports activities, sleeping habits, etc.)
8. Subject is under effective contraception (oral/not oral) therapy
9. Subjects who accept not to expose in an intensive way to UV rays during the whole study duration
10. Subjects registered with Nation Health Service (NHS)
11. Subjects certifying the truthfulness of the personal data disclosed to the investigator
12. Subjects able to understand the language used in the investigation center and the information given by the investigator
13. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
14. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
15. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
1. Subject does not meet the inclusion criteria
2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
3. Subjects participating or planning to participate in other clinical trials
4. Subjects not able to be contacted in case of emergency
5. Subjects admitted to a health or social facility
6. Subjects planning a hospitalization during the study
7. Subjects who participated in a similar study without respecting an adequate washout period (at least one month of wash-out)
8. Subject with known or suspected sensitization to one or more test formulation ingredients
9. Having a diagnosed chronic disease (blood, cardio-vascular, psychiatric, neuro-degenerative, cancer, liver, gastric, skin, etc.) and/or under medical treatment; in particular subjects suffering from hypertension, renal insufficiency, liver cirrhosis and diabetes will be excluded from the trial
10. Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study: moreover the assumption of foods containing liquorice is not recommended for the entire duration of the study
11. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
12. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
13. Subjects accustomed to using tanning beds
14. Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study
15. Subjects under pharmacological treatments that are considered incompatible with the study requirements by the investigator
16. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
17. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patches or medical devices
18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The whitening efficacy of the tested treatment will be evaluated by:<br> 1. Evaluation of spots and skin individual typology angle (ITA) measured using a spectrophotometer/colorimeter CM-700D (Konica-Minolta) at T0, T28, and T56 (days)<br> 2. Evaluation of skin radiance/skin brightness measured using a spectrophotometer/colorimeter CM-700D (Konica-Minolta) at T0, T28, and T56<br> 3. Clinical evaluation of skin evenness complexion and whitening efficacy on Visia pictures measured using an improvement clinical scale (from 1: no variation to 4: remarkable improvement) at T28 and T56<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Measurement of the variation of the levels of accumulated advanced glycation end products (AGE) measured using an AGE Reader mu of DiagnOptics Technologies B.V at T0 and T56<br> 2. An evaluation of face digital pictures measured using means of Visia®-CR (Canfield Scientific) at T0, T28, T56<br> 3. Product acceptability and volunteers’ perceived efficacy measured using a self-assessment questionnaire at T28 and T56<br>