A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects

Exclusion Criteria

• •Participants with Fitzpatrick skin types of 1, 4, 5 or 6
• •Known allergies or sensitivity to tomato, latex and/or potato
• •Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
• •Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as \>10 consecutive days
• •Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
• •Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period
• •Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
• •Currently active herpes infections or currently on treatment for herpes infections
• •History of facial keloids
• •Current diagnosis of adult acne or currently on treatment for adult acne
• •Recent (\<6 months at enrollment) cardiovascular conditions such as stroke, transient ischemic attack (TIA), or myocardial ischemia/infarction, recently on treatment for congestive heart failure, or currently having vasculitis or vascular conditions
• •On potent blood thinners such as low-molecular weight heparin (LMWH), rivaroxaban, apixaban, or other prescription blood thinners - excludes aspirin
• •Holds a current diagnosis of diabetes mellitus type I or II
• •Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study
• •Chronic liver disease- excluding early stage non-alcoholic fatty liver disease (NAFLD)
• •Chronic kidney disease or recent (\<6 months at enrollment) acute kidney disease
• •Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan
• •Participants with occupations or lifestyle that require significant daily exposure to the sun (defined as at least 1 hour of continuous outdoor sun exposure)
• •Participants who have had a sunburn in the last 2 weeks
• •Participants who use tanning salons or tanning products in the last 3 months
• •Participants who plan to undergo invasive facial procedures (injections, chemical peeling, etc.) during the study or have undergone these procedures within 2 months prior to enrollment
• •Change in oral supplements or medications targeting skin health within 2 months prior to enrollment
• •Participants who are HIV positive
• •Participants who are immunosuppressed
• •Participants with a recent (\<2 months prior to enrollment) diagnosis of a psychiatric condition
• •Participants having chronic connective tissue disorder affecting the skin (e.g. Ehlers- Danlos syndrome, Marfan's Syndrome, Osteogenesis Imperfecta)
• •Participants with auto-immune skin diseases (e.g. scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis)
• •Participants who have been prescribed retinoids treatment (\<2 months prior to enrollment)
• •Participants who meet either/or both of the following criteria with regards to smoking habits (smoking includes cigarettes, e-cigs, pipes, hookah, cigars):
• •Who are current smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime) and who continue to use these products
• •Who were former smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime, but who have quit smoking) who have smoked within the last year and/or were former smokers for 10 years
• •Participants who drink more than 14 drinks per week (more than 2 drinks per night)
• •Participants who use illicit or illegal drugs
• •Participants who are regular users of cannabis substances or substances derived from cannabis such as CBD, CBD oils or balms, cannabis-containing edibles; vaping; smoking; hookahs.
• •NOTE: regular use is defined as long stretches of inhaling or consuming these products over several months or longer. Occasional, but not weekly, use of products with small amounts of CBD-related compounds (e.g. waters with CBD infusions) are not considered regular use.)
• •Participants who are planning a trip to the mountains or to a higher UV index region during the study period
• •Any other medication, condition or disease that in the PI's opinion that may adversely affect the participant's ability to complete the study, substantially impact the study's integrity or may pose a significant risk to the participant
• •Participants who are experiencing perimenopausal or menopausal symptoms
• •Participants who have had a hysterectomy and/or both of their ovaries removed