Clinical trial NCT04356456: A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin
Keywords: Nutritional Supplement
Lead sponsor: LycoRed Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization at 1:1 ratio for active or placebo
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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: 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: VISIA-CR® images of each subject's face
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
Locations:
city: Fairfield
country: United States
facility: Consumer product testing (CPT)
state: New Jersey
Study officials:
affiliation: CPT
name: Michael Caswell, PhD
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.