Status:
WITHDRAWN
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lumenato and Its Impact on Skin Parameters in Healthy Female Subjects
Lead Sponsor:
LycoRed Ltd.
Conditions:
Skin
Eligibility:
FEMALE
35-55 years
Phase:
NA
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...
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04356456
Start Date
January 14 2020
End Date
August 8 2020
Last Update
November 13 2020
Active Locations (1)
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1
Consumer product testing (CPT)
Fairfield, New Jersey, United States, 07004