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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin
• Intervention / Treatment: Dietary supplement: Lumenato

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Eurofins | CRL, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lumenato; 1 Lumenato soft gel once a day	Dietary supplement: Lumenato; Supplementation of 12 weeks
PLACEBO_COMPARATOR: Placebo; 1 Soft gels without active ingredients once a day	Dietary supplement: Lumenato; Supplementation of 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LycoRed Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2022
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): August 31, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: September 11, 2022
• First Posted (ACTUAL): September 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CRLNJ2021-0990 BI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No