Clinical trial: Lumenato Nutritional Supplement on Skin Appearance (NCT04248699)

Eligibility criteria:
Inclusion criteria:

          -  Resides in the United States

          -  Generally healthy women between the ages of 35-55

          -  Fitzpatrick skin types 2 or 3

          -  Identifies as one of the following: Asian, White, Hispanic/Latino, or both White and
             Hispanic/Latino

          -  Type 2 on the Glogau Skin Classification scale

          -  Has expressed interest in improving skin health and appearance

          -  Willing and able to follow the procedures of the study

          -  Willing to refrain from changing their diet or lifestyle significantly for the
             duration of the study

          -  Able to understand the study requirements and activities in English, and provide
             informed consent

          -  Access to reliable internet service and smartphone in order to utilize the ClaimIt
             software/app needed to remotely participate in the study

        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
Female
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? 0