SkinNCT04248699

Lumenato Nutritional Supplement on Skin Appearance

A study testing Lumenato in people with Skin, run by LycoRed Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance. 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?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2020to 8 Jul 2020
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

Resides in the United States
Generally healthy women between the ages of 35-55
Fitzpatrick skin types 2 or 3
Identifies as one of the following: Asian, White, Hispanic/Latino, or both White and Hispanic/Latino
Type 2 on the Glogau Skin Classification scale
Has expressed interest in improving skin health and appearance

Show all 10Show fewer

Willing and able to follow the procedures of the study
Willing to refrain from changing their diet or lifestyle significantly for the duration of the study
Able to understand the study requirements and activities in English, and provide informed consent
Access to reliable internet service and smartphone in order to utilize the ClaimIt software/app needed to remotely participate in the study

Who cannot join

Participants with Fitzpatrick skin types of 1, 4, 5 or 6
Known allergies or sensitivity to tomato, latex and/or potato
Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as >10 consecutive days
Chronic or relapsing inflammatory and/or allergic skin conditions such as atopic dermatitis, rosacea, psoriasis and alike including telangiectasias ("spider veins")
Pregnant, lactating or breastfeeding women (within the last 6 months) or those planning to become pregnant during the study period

Show all 39Show fewer

Less than 2 years since diagnosis or treatment of skin cancer including basal cell carcinoma, squamous cell carcinoma, melanoma- excluding actinic keratosis
Currently active herpes infections or currently on treatment for herpes infections
History of facial keloids
Current diagnosis of adult acne or currently on treatment for adult acne
Recent (<6 months at enrollment) cardiovascular conditions such as stroke, transient ischemic attack (TIA), or myocardial ischemia/infarction, recently on treatment for congestive heart failure, or currently having vasculitis or vascular conditions
On potent blood thinners such as low-molecular weight heparin (LMWH), rivaroxaban, apixaban, or other prescription blood thinners - excludes aspirin
Holds a current diagnosis of diabetes mellitus type I or II
Participants who have received facial irradiation within last year or are planning on undergoing facial irradiation during the study
Chronic liver disease- excluding early stage non-alcoholic fatty liver disease (NAFLD)
Chronic kidney disease or recent (<6 months at enrollment) acute kidney disease
Participants who currently take supplements containing carotenoids, lutein, melatonin or tryptophan
Participants with occupations or lifestyle that require significant daily exposure to the sun (defined as at least 1 hour of continuous outdoor sun exposure)
Participants who have had a sunburn in the last 2 weeks
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
Change in oral supplements or medications targeting skin health within 2 months prior to enrollment
Participants who are HIV positive
Participants who are immunosuppressed
Participants with a recent (<2 months prior to enrollment) diagnosis of a psychiatric condition
Participants having chronic connective tissue disorder affecting the skin (e.g. Ehlers- Danlos syndrome, Marfan's Syndrome, Osteogenesis Imperfecta)
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)
Participants who meet either/or both of the following criteria with regards to smoking habits (smoking includes cigarettes, e-cigs, pipes, hookah, cigars):
Who are current smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime) and who continue to use these products
Who were former smokers (smoked at least 100 cigarettes, or tobacco/nicotine equivalent, in her lifetime, but who have quit smoking) who have smoked within the last year and/or were former smokers for 10 years
Participants who drink more than 14 drinks per week (more than 2 drinks per night)
Participants who use illicit or illegal drugs
Participants who are regular users of cannabis substances or substances derived from cannabis such as CBD, CBD oils or balms, cannabis-containing edibles; vaping; smoking; hookahs.
NOTE: regular use is defined as long stretches of inhaling or consuming these products over several months or longer. Occasional, but not weekly, use of products with small amounts of CBD-related compounds (e.g. waters with CBD infusions) are not considered regular use.)
Participants who are planning a trip to the mountains or to a higher UV index region during the study period
Any other medication, condition or disease that in the PI's opinion that may adversely affect the participant's ability to complete the study, substantially impact the study's integrity or may pose a significant risk to the participant
Participants who are experiencing perimenopausal or menopausal symptoms
Participants who have had a hysterectomy and/or both of their ovaries removed

Trial locations and contacts

1 site in 1 country.

United States1 site

o ObvioHealth
Orlando, Florida, 32817

Other trials in United States

About this study

Official title: Open-Label Study to Assess the Impact of Lycored's Nutritional Supplement Lumenato on Skin Parameters in Healthy Women

This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance.

Read the detailed description

The purpose of this study is to evaluate perceived changes in skin health and appearance after taking the study product daily for 12 weeks. The study product is a soft gel supplement containing tomato oil. This an open-label study, meaning there is no placebo control arm for the study, and everyone enrolled in the study will receive the active study product.

Conditions: Skin
Being tested: Lumenato
Keywords: Nutritional Supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LumenatoDietary supplement
tomato oleoresin obtained from yellow dry tomato pulp

Study groups in NCT04248699
Study group	Role	What they receive
Lumenato Supplement	Experimental	tomato oleoresin Receives: Dietary Supplement: Lumenato

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).
Measured: 12 weeks

Secondary outcomes (3)

Baseline Skin Questionnaire
Participant perception of change or maintenance in a variety of skin health parameters over the course of the study using the subjective "Baseline Skin Questionnaire"
Measured: 12 weeks
End of Study Product Questionnaire"
Participant perception of the study product and study experience as assessed by the "End of Study Product Questionnaire"
Measured: 12 weeks
Skin Update Questionnaire
Participant perception of change or maintenance in a variety of skin health parameters over the course of the study using the subjective "Update Skin Questionnaire"
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 20208 Jul 2020

First posted30 Jan 2020
Study start14 Jan 2020
Primary completion8 Jun 2020
Study completion8 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248699
Sponsor's protocol ID: OBVIO-LYC-002
Status last verified: Jan 2020
First submitted: 27 Jan 2020
Last updated: 18 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.
PubMed 8948530
Groten K, Marini A, Grether-Beck S, Jaenicke T, Ibbotson SH, Moseley H, Ferguson J, Krutmann J. Tomato Phytonutrients Balance UV Response: Results from a Double-Blind, Randomized, Placebo-Controlled Study. Skin Pharmacol Physiol. 2019;32(2):101-108. doi: 10.1159/000497104. Epub 2019 Mar 5.
PubMed 30836363
Havas F, Krispin S, Melendez-Martinez AJ, von Oppen-Bezalel L. Preliminary Data on the Safety of Phytoene- and Phytofluene-Rich Products for Human Use including Topical Application. J Toxicol. 2018 Apr 15;2018:5475784. doi: 10.1155/2018/5475784. eCollection 2018.
PubMed 29849613
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Study to Assess the Impact of Lycored's Nutritional Supplement Lumenato on Skin Parameters in Healthy Women
ClinicalTrials.gov ID: NCT04248699
Acronym / sponsor ID: OBVIO-LYC-002
Conditions: Skin
Keywords: Nutritional Supplement
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: LycoRed Ltd.Industry (pharma, biotech, devices)
Collaborators: ObvioHealth
Study start: 14 Jan 2020 (actual)
Primary completion: 8 Jun 2020 (actual)
Study completion: 8 Jul 2020 (actual)
First posted: 30 Jan 2020 (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.

This 12-week study is an open-label study assessing the perceived effectiveness of the Lycored Lumenato supplement on skin health and appearance.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lumenato Supplement	Experimental	Dietary Supplement: Lumenatotomato oleoresin

Who may qualify

Ages: 35 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Resides in the United States
Generally healthy women between the ages of 35-55
Fitzpatrick skin types 2 or 3
Identifies as one of the following: Asian, White, Hispanic/Latino, or both White and Hispanic/Latino
Type 2 on the Glogau Skin Classification scale

Key exclusion criteria (39 listed)

Participants with Fitzpatrick skin types of 1, 4, 5 or 6
Known allergies or sensitivity to tomato, latex and/or potato
Current use or use within 1 month of study enrollment of hormonal therapies (including hormonal contraceptives)
Current, regular use or regular use within 1 month of study enrollment of oral steroids; regular use defined as >10 consecutive days
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
Lumenatotomato oleoresin obtained from yellow dry tomato pulp	Dietary supplement	Lumenato Supplement

Primary outcome

Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
Time frame: 12 weeks
FACE-Q™ Satisfaction with Skin scale: gathers the participant perspective of their satisfaction or dissatisfaction with their facial skin using a 12-question scale. Participants are asked to choose one of the following responses for each question: Very Dissatisfied (1), Somewhat Dissatisfied (2), Somewhat Satisfied (3) and Very Satisfied (4) for each 12 questions and the sum of scores (or mean of the completed items, in the event of an incomplete scale) gets converted into a score from 0 (worst) to 100 (best).

3 secondary outcomes

Baseline Skin Questionnaire
Time frame: 12 weeks
End of Study Product Questionnaire"
Time frame: 12 weeks
Skin Update Questionnaire
Time frame: 12 weeks

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 18 Aug 2020.
Background: PubMed 8948530Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.
Background: PubMed 30836363Groten K, Marini A, Grether-Beck S, Jaenicke T, Ibbotson SH, Moseley H, Ferguson J, Krutmann J. Tomato Phytonutrients Balance UV Response: Results from a Double-Blind, Randomized, Placebo-Controlled Study. Skin Pharmacol Physiol. 2019;32(2):101-108. doi: 10.1159/000497104. Epub 2019 Mar 5.
Background: PubMed 29849613Havas F, Krispin S, Melendez-Martinez AJ, von Oppen-Bezalel L. Preliminary Data on the Safety of Phytoene- and Phytofluene-Rich Products for Human Use including Topical Application. J Toxicol. 2018 Apr 15;2018:5475784. doi: 10.1155/2018/5475784. eCollection 2018.
Results publication: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
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.

Parth Shah, MD principal investigator

ObvioHealth

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 10 inclusion and 39 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 18 Aug 2020. 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. 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?

Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™ (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248699, which also lists 4 linked publications.

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 18 Aug 2020.