A Clinical Study to Evaluate the Efficacy and Consumer Perception of Lumenato

Study Overview
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Brief Summary
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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.

Official Title
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A 12 Weeks of Clinical Study to Evaluate the Efficacy and Consumer Perception of Different Skin Attributes Following Supplementation of an Oral Supplement- Lumenato

Conditions
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Skin

Intervention / Treatment
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* Dietary Supplement: Lumenato


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is female between 35 and 55 years of age; Subject has a Fitzpatrick skin type of II, III, or IV; Subject is of Caucasian or Latino; 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); Subject to have a baseline TEWL of ≥12; Subject to have Glogau skin classification of Type 2 (see Appendix IV); Subject is willing to get their blood drawn at Baseline and Week 4; 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; Subject agrees not to introduce any new nutricosmetic, cosmetic or toiletry products during the study; Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits; Subject is willing to participate in all study evaluations; Subject is in generally good health and has a current Panelist Profile Form on file at CRL; Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study ; Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: Protection of Human Subjects. Exclusion Criteria: Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control; Subject has a history of digestive problems; Subject is on blood thinners; 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; Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias (spider veins); Current diagnosis of adult acne or currently on treatment for adult acne; Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study; Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan; 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; 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); Current smokers; 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; Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; Subject is not willing to participate in all study evaluations; Subject has known allergies to skin treatment products or cosmetics, toiletries, nutraceuticals, nutricosmetic, and/or topical drugs; Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; Subject has diabetes.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumenato<br>1 Lumenato soft gel once a day | Dietary Supplement: Lumenato<br>* Supplementation of 12 weeks<br>|
| Placebo Comparator: Placebo<br>1 Soft gels without active ingredients once a day | Dietary Supplement: Lumenato<br>* Supplementation of 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire | VapoMeter Measurements before and after treatment FaceQ questionnaire before and after treatment | 12 weeks of use |