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

NCT ID: NCT05537350

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2022-08-31

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.

Conditions

Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Lumenato

1 Lumenato soft gel once a day

Group Type: EXPERIMENTAL

Lumenato

Intervention Type: DIETARY_SUPPLEMENT

Supplementation of 12 weeks

Placebo

1 Soft gels without active ingredients once a day

Group Type: PLACEBO_COMPARATOR

Lumenato

Intervention Type: DIETARY_SUPPLEMENT

Supplementation of 12 weeks

Interventions

Lumenato

Supplementation of 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

LycoRed Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins | CRL, Inc.

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

CRLNJ2021-0990 BI

Identifier Type: -

Identifier Source: org_study_id