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

NCT05537350 | Completed

• 1 other identifier: CRLNJ2021-0990 BI
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lumenato

EXPERIMENTAL

1 Lumenato soft gel once a day

Dietary Supplement: Lumenato

Placebo

PLACEBO COMPARATOR

1 Soft gels without active ingredients once a day

Dietary Supplement: Lumenato

Interventions

Lumenato DIETARY_SUPPLEMENT

Supplementation of 12 weeks

Lumenato; Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• LycoRed Ltd.: lead

Study Sites (1)

Eurofins | CRL, Inc.

Piscataway, New Jersey, 08854, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: September 13, 2022
• Study Start: January 4, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 31, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)