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

Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537350
• Other study ID #: CRLNJ2021-0990 BI
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: LycoRed Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

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.

Related Conditions & MeSH terms

• Skin

Intervention

Dietary Supplement:
• Lumenato
Supplementation of 12 weeks

Locations

Country	Name	City	State
United States	Eurofins | CRL, Inc.	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
LycoRed Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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