Clinical trial NCT04248699: Lumenato Nutritional Supplement on Skin Appearance
Official title: Open-Label Study to Assess the Impact of Lycored's Nutritional Supplement Lumenato on Skin Parameters in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin
Keywords: Nutritional Supplement
Lead sponsor: LycoRed Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2020-01-30
Enrollment: 72
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion criteria:

* 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
* 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:

* 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
* 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

Primary outcomes:
measure: Participant perception of the improvement in skin health and appearance from Baseline to Week 12 using the questionnaire responses from FACE-Q™
timeFrame: 12 weeks
Secondary outcomes:
measure: Baseline Skin Questionnaire
timeFrame: 12 weeks
measure: End of Study Product Questionnaire"
timeFrame: 12 weeks
measure: Skin Update Questionnaire
timeFrame: 12 weeks
Other outcomes:
measure: Adverse events (AEs) observed during the study, classified by the investigator as to severity, relationship to the study product/protocol, and seriousness
timeFrame: 14 weeks
measure: Compliance to the daily use of the Lycored Lumenato supplement through monitoring within ClaimIt (Weekly e-Diary)
timeFrame: 12 weeks
measure: Sustainability of effect after two weeks without supplementation as assessed by the Week 14 FACE-Q™ Satisfaction with Skin scale
timeFrame: 14 weeks
Locations:
city: Orlando
country: United States
facility: o ObvioHealth
state: Florida
Study officials:
affiliation: ObvioHealth
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.