Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters

Completed · Not applicable · Has a placebo group

Conditions studied: Skin Care

In brief

Carotenoids and polyphenols are assumed to have an active role in skin health. Sources for these phytonutrient are fruits and vegetables. They are widely applied as skin protectants, and supplementation with carotenoids have shown to protect against erythema caused by UV-radiation. UV radiation generates reactive oxygen species in the skin, which induces cellular signaling that may impair cell cycle, cell growth, and regeneration or repair processes.

Key facts

Study ID

NCT03402373

Run by

LycoRed Ltd.

People needed

60

Starts

2017-11-17

Expected to finish

2019-05-30

Last updated by the study team

2019-07-02

Who can join

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

You may qualify if…

• Females between ages of 35 and 55 years old, inclusive at enrollment
• Subjects in good general health with no serious illnesses which might interfere with study participation per assessment of investigator.
• Subjects with BMI <30 kg/m2
• Nonsmokers (self-reported)
• Agree to maintain current dietary regimen
• Agree to maintain current cosmetic regimen
• Skin Type II/ III.
• Subjects with dull skin, lack of radiance, uneven skin tone, lines and wrinkles as determined by an expert grader at Baseline.

You may not qualify if…

• Subjects with known allergies to soybeans, coconut, tomatoes, or rosemary.
• Subjects that are not willing to to maintain current dietary regimen
• Subjects that underwent extensive sunbathing in the month before study initiation or who plan to have excessive sun exposure or use a tanning bed/booth during the study.
• Subjects that underwent procedures using injectables such as Botox or other fillers in 2 months before screening or who plan to undergo such procedures during the study.
• Subjects with drastic change in body weight (greater than 10% 1 month prior to screening or during the study
• Intake of vitamin or dietary supplements (especially Vitamin D3, carotenoids) during the month prior to screening
• History of malabsorption diseases, liver diseases, or diseases of lipid metabolism.
• History of photosensitizing disorders.
• Use of medications which interact with the study procedures according to the principal investigator (during or prior to the study).
• Subjects currently participating in a study or who have participated in any other clinical studies during the last 3 months prior to the study
• Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes.
• History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
• Immunocompromised subjects .
• Woman who started Hormone Replacement Therapy within the last three months preceding the screening visit.
• Woman using oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the Baseline visit or planning to modify her contraception treatment within the duration of the study.
• Woman known to be pregnant, lactating or planning to become pregnant within six months. Subjects who become pregnant during the study must inform the Principal Investigator immediately and will be excluded from the study.

Where it is running

• International Research Services, Inc. — Port Chester, New York, United States

Full record on ClinicalTrials.gov

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