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CompletedNCT05537350Updated Sep 13, 2022

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

An interventional study of Lumenato in Skin, sponsored by LycoRed Ltd.. Completed at 1 site in United States. Open to female participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by LycoRed Ltd. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2022, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
35 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Skin
03

In context

Lead sponsor

LycoRed Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Lumenato

    1 Lumenato soft gel once a day

    Dietary Supplement: Lumenato

  • Placebo comparator
    Placebo

    1 Soft gels without active ingredients once a day

    Dietary Supplement: Lumenato

Interventions

  • Dietary supplementLumenato

    Supplementation of 12 weeks

06

What researchers measure

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

    Time frame: 12 weeks of use

07

Study locations

1 site
  • Eurofins | CRL, Inc.
    Piscataway, New Jersey 08854, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537350
Lead sponsor
LycoRed Ltd.
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Jan 4, 2022
Primary completion
Jun 1, 2022
Completion
Aug 31, 2022
Last update
Sep 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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