A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects
NCT ID: NCT04356456
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-01-14
2020-08-08
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Lumenato Supplement
Lumenato oleoresin
Lumenato
tomato oleoresin obtained from yellow dry tomato pulp
Placebo
paraffin oil
Lumenato
tomato oleoresin obtained from yellow dry tomato pulp
Interventions
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Lumenato
tomato oleoresin obtained from yellow dry tomato pulp
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
35 Years
55 Years
FEMALE
Yes
Sponsors
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LycoRed Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Caswell, PhD
Role: PRINCIPAL_INVESTIGATOR
CPT
Locations
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Consumer product testing (CPT)
Fairfield, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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LSDH02-001
Identifier Type: -
Identifier Source: org_study_id