SkinNCT05537350
A Clinical Study to Evaluate the Efficacy and Consumer Perception of Lumenato
A study testing Lumenato in people with Skin, run by LycoRed Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin
- What is being tested?
- Lumenato
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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."
Who cannot join
- 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;
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- 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;
- Subject is not willing to participate in all study evaluations;
- Subject has known allergies to skin treatment products or cosmetics, toiletries, nutraceuticals, nutricosmetic, and/or topical drugs;
- Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
- Subject has diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Lumenato
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumenatoDietary supplement
Supplementation of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lumenato | Experimental | 1 Lumenato soft gel once a day Receives: Dietary Supplement: Lumenato |
| Placebo | Placebo comparator | 1 Soft gels without active ingredients once a day Receives: Dietary Supplement: Lumenato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire
VapoMeter Measurements before and after treatment FaceQ questionnaire before and after treatment
Measured: 12 weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start4 Jan 2022
- Primary completion1 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537350
- Sponsor's protocol ID
- CRLNJ2021-0990 BI
- Status last verified
- Sep 2022
- First submitted
- 11 May 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05537350
- Acronym / sponsor ID
- CRLNJ2021-0990 BI
- Conditions
- Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumenato | Experimental | Dietary Supplement: Lumenato1 Lumenato soft gel once a day |
| Placebo | Placebo comparator | Dietary Supplement: Lumenato1 Soft gels without active ingredients once a day |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (19 listed)
- 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");
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumenatoSupplementation of 12 weeks | Dietary supplement | Lumenato, Placebo |
Primary outcome
Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire
Time frame: 12 weeks of use
VapoMeter Measurements before and after treatment FaceQ questionnaire before and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenato in people with Skin, run by LycoRed Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvment of skin barier as mesured by VapoMeter and FaceQ questionnaire (time frame: 12 weeks of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.