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

Completed · Not applicable · Has a placebo group

Conditions studied: Skin

In brief

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.

Key facts

Study ID

NCT05537350

Run by

LycoRed Ltd.

People needed

66

Starts

2022-01-04

Expected to finish

2022-08-31

Last updated by the study team

2022-09-13

Who can join

Age: 35 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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."

You may not qualify if…

• 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.

Where it is running

• Eurofins | CRL, Inc. — Piscataway, New Jersey, United States

Full record on ClinicalTrials.gov

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