Skin
Conditions
Brief summary
Subjects will be enrolled in this clinical study to assess the efficacy of an oral supplement to change the characteristics of facial skin after 4 and 12 weeks of use and obtain consumer perception of the test product through the use of questionnaires. Study evaluations will include a comprehensive metabolic panel, Cutometer measurements, Canfield's VISIA-CR images, VapoMeter Measurements, and Consumer perception questionnaires.
Interventions
DIETARY_SUPPLEMENTLumenato
Supplementation of 12 weeks
Sponsors
LycoRed Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is female between 35 and 55 years of age; 2. Subject has a Fitzpatrick skin type of II, III, or IV; 3. Subject is of Caucasian or Latino; 4. Subject has self-perceived sensitive skin (defined as being sensitive to different topical products through different seasons resulting in any of the following: redness, irritation, itching, tingling, or edema); 5. Subject to have a baseline TEWL of ≥12; 6. Subject to have Glogau skin classification of Type 2 (see Appendix IV); 7. Subject is willing to get their blood drawn at Baseline and Week 4; 8. Subject is not currently enrolled in, and agrees not to participate in, any other oral nutritional supplement or face studies while enrolled in this study; 9. Subject agrees not to introduce any new nutricosmetic, cosmetic or toiletry products during the study; 10. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits; 11. Subject is willing to participate in all study evaluations; 12. Subject is in generally good health and has a current Panelist Profile Form on file at CRL; 13. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study ; 14. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; 15. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: Protection of Human Subjects.
Exclusion criteria
1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control; 2. Subject has a history of digestive problems; 3. Subject is on blood thinners; 4. Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within 4 week prior to initiation of the study; 5. Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias (spider veins); 6. Current diagnosis of adult acne or currently on treatment for adult acne; 7. Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study; 8. Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan; 9. Participants who use tanning salons or tanning products in the last 3 months; 10. 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; 11. Participants with auto-immune skin diseases (e.g. scleroderma, psoriasis, lupus, epidermolysis bullosa, bullous pemphigoid, temporal arteritis); 12. Participants who have been prescribed retinoids treatment (\<2 months prior to enrollment); 13. Current smokers; 14. Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study; 15. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; 16. Subject is not willing to participate in all study evaluations; 17. Subject has known allergies to skin treatment products or cosmetics, toiletries, nutraceuticals, nutricosmetic, and/or topical drugs; 18. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; 19. Subject has diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire | 12 weeks of use | VapoMeter Measurements before and after treatment FaceQ questionnaire before and after treatment |
Countries
United States
Outcome results
None listed