| Eligibility |
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.
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