Efficacy of a food supplement in protecting the skin from the sun and reducing dark spots

INTERVENTION: The active food supplement intervention is composed of grape seed extract, licorice root extract, grape pomace extract and coated vitamin C, while the placebo food supplement intervention is: maltodextrin. Both the active and the placebo products are used as follows: one capsule per day to be taken during breakfast with a glass of still water for 84 days. To standardize the volunteer’s cosmetic habits, a base face cream with SPF without any cosmetic activity is provided for use during the whole study period instead of their usual day/night face cream. Test subjects are randomized into two groups of 30 (33) subjects as follows: one group takes the active food supplement and one group takes the placebo food supplement, A restricted randomization list is created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64‐bit Edition (Microsoft, USA) by a biostatistician and stored in a safe place. The randomization sequence was stratified using “Efron’s biased coin” algorithm with a 1:1 allocation ratio. The allocation sequence was concealed from the in‐site study director in sequentially numbered, opaque and sealed envelopes, reporting the unblinded treatment allocation (based on the subject entry number in the study). The A4 sheet reporting the unblinded treatment was folded to render the envelope impermeable to intense light. A masked allocation sequence was prepared for the staff delivering the intervention based on the subject entry number in the study. CONDITION: Subjects with phototypes from I to III, showing hyperpigmentation, with at least one spot with a minimum diameter of 3 mm ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: UV protection evaluated by the assessment of the minimal erythemal dose (MED) at T0, T42 and T84. MED is performed by applying a series of UV exposures, using a model 601‐300W solar simulator (Solar Light Co. Inc, Philadelphia, USA). Skin redness reaction after UV exposure is measured in the MED skin site using a colorimeter/spectrophotometer CM‐700D (Konica Minolta). The parameter measured is the a* parameter of the CIELAB (1976) chromatic space. Digital pictures of the MED area were acquired using a digital camera at baseline (T0), 42 days (T42) and 84 days (T84). SECONDARY OUTCOME: 1. Spots individual typology angle (ITA) measured using a spectrophotometer/colorimeter CM‐700D (Konica‐Minolta) at T0, T42, and T84 (days); 2. L* parameter (that defines the color brightness) on spots measured using a spectrophotometer/colorimeter CM‐700D (Konica‐Minolta) at T0, T42, and T84 (days); 3. Percentage of the skin area occupied by dark spots at T0, T42, and T84 (days), measured by means of a image analysis technique using the thresholding (segmentation) algorithm on RB Xbrown Visia®‐CR pictures (Canfield Scientific). ; 4. Short‐term effects of the dietary supplement on UV protection evaluated by the assessment of the minimal erythemal dose (MED). at the T0 and 24 h after the first product intake (pilot study performed on 10 subjects per arm). MED is performed by applying a series of UV exposures, using a model 601‐300W solar simulator (Solar Light Co. Inc, Philadelphia, USA). Skin redness reaction after UV exposure is measured in the MED skin site using a colorimeter/spectrophotometer CM‐700D (Konica Minolta). The parameter measured is the a* parameter of the CIELAB (1976) chromatic space. Digital pictures of the MED area acquired using a digital camera at baseline (T0) and at T24h.; 5. Clinical evaluation of skin evenness complexion and whitening efficacy on Visia®‐CR pictures (Canfield Scientific) using an improvement clinical scale (from 1: no variation to 4: remarkable improvement) at T42 and T84; 6. Product safety assessed using adverse events recording throughout the study (T42 and T84); 7. Product acceptability and volunteers’ perceived efficacy assessed with a self‐assessment questionnaire at T84 INCLUSION CRITERIA: 1. Healthy female (80%) and male (20%) 2. Caucasian ethnicity 3. Phototypes from I to III 4. Age between 28 and 52 years inclusive 5. Subject showing skin spots related to age, sun exposure or post‐inflammatory hyperpigmentation, with at least one spot with a minimum diameter of 3 mm 6. Willingness to not consume during the study period products other than the test product as judged by the investigator, 7. Subjects registered with the National Health Service (NHS) 8. Subjects certifying the truthfulness of the personal data disclosed to the investigator 9. Subjects able to understand the language used in the investigation centre and the information given by the investigator 10. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 11. The pharmacological therapy (except for the pharmacological therapy in the non‐inclusion criteria) should be stable