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SkinNCT04356456

A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects

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

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. cored 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?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
14 Jan 2020to 8 Aug 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: 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

  • Consumer product testing (CPT)

    Fairfield, New Jersey, 07004

Other trials in United States

About this study

Official title: Randomized and Double-blinded Study Designed to Evaluate and Compare the Efficacy of a Once a Day Dietary Supplement to Reduce the Appearance of Wrinkles and Uneven Skin Tone and to Diminish the Appearance of Fine Lines and Wrinkles, to Affect Skin Complexion and Texture and to Strengthen the Skin Barrier, Over the Course of a 12-week Use Period, and 2 Weeks Post Usage

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. cored Lumenato supplement on skin health and appearance.

Read the detailed description

This is a pilot study, randomized and double-blinded designed to evaluate and compare the efficacy of a once a day dietary supplement to reduce the appearance of wrinkles and uneven skin tone and to diminish the appearance of fine lines and wrinkles, to affect skin complexion and texture and to strengthen the skin barrier, over the course of a 12-week use period, and 2 weeks post usage.

Randomization at 1:1 ratio and is done by the sponsor. The product will arrive blinded (with the kit number stated on the label) neither subjects nor study staff will know the identity of the test products. A sequential number of bottles will be assigned to every enrolled subject.

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 NCT04356456
Study groupRoleWhat they receive
Lumenato SupplementExperimentalLumenato oleoresin
Receives: Dietary Supplement: Lumenato
PlaceboPlacebo comparatorparaffin oil
Receives: Dietary Supplement: Lumenato

What is being measured

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

  1. VISIA-CR® images of each subject's face

    VISIA-CR® takes a series of standardized, reproducible digital facial images, inside of a controlled lighting environment. Subjects' front, left, and right views will be captured with their eyes gently closed using the following lighting parameters.

    Measured: 12 weeks

Secondary outcomes (3)

  1. 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

  2. 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

  3. 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.

  1. First posted22 Apr 2020
  2. Study start14 Jan 2020
  3. Primary completion30 Jun 2020
  4. Study completion8 Aug 2020

Why it stopped: Covid-19

Resources

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
Model description
Randomization at 1:1 ratio for active or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356456
Sponsor's protocol ID
LSDH02-001
Status last verified
Apr 2020
First submitted
19 Apr 2020
Last updated
13 Nov 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

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: withdrawn, as of the sponsor's last update on 13 Nov 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

VISIA-CR® images of each subject's face (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 NCT04356456, 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 13 Nov 2020.

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