Status:

COMPLETED

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

Lead Sponsor:

LycoRed Ltd.

Conditions:

Skin Care

Eligibility:

FEMALE

35-55 years

Phase:

NA

Brief Summary

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 supplementati...

Detailed Description

The face holds an integral role in human social communication and how humans are perceived as attractive. In addition to structural facial features, studies have shown that skin appearance is highly w...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • 17\. 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.
  • \-

Key Trial Info

Start Date :

November 17 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 30 2019

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT03402373

Start Date

November 17 2017

End Date

May 30 2019

Last Update

July 2 2019

Active Locations (1)

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International Research Services, Inc.

Port Chester, New York, United States, 10573