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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Skin

In brief

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.

Key facts

Study ID

NCT04356456

Run by

LycoRed Ltd.

People needed

0

Starts

2020-01-14

Expected to finish

2020-08-08

Last updated by the study team

2020-11-13

Who can join

Age: 35 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Consumer product testing (CPT) — Fairfield, New Jersey, United States

Full record on ClinicalTrials.gov

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