Clinical trial NCT03402373: Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters
Official title: A 16-Week Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: LycoRed Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 60
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: Double Blind, Randomized, Placebo-Controlled
Primary purpose: SUPPORTIVE_CARE

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 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.

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 weighed in the perception of beauty and is determined primarily by its coloration and surface topography. Aging is caused by two processes, intrinsic and extrinsic. The sun is the primary cause of extrinsic aging and has also been shown to alter the normal course of intrinsic or natural aging. On the molecular level, various hypotheses have been proposed to explain aging, with free radical theory being prominent. The free radical theory addresses the concept of intrinsic biological instability of living systems, in which free radicals and other reactive oxygen species (ROS) damage biomolecules, and this damage results in aging of the skin (as well as other systems).

The aim of this study is to examine the effects of an oral antioxidant supplement on skin aging and skin condition.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects with known allergies to soybeans, coconut, tomatoes, or rosemary.
2. Subjects that are not willing to to maintain current dietary regimen
3. 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.
4. 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.
5. Subjects with drastic change in body weight (greater than 10% 1 month prior to screening or during the study
6. Intake of vitamin or dietary supplements (especially Vitamin D3, carotenoids) during the month prior to screening
7. History of malabsorption diseases, liver diseases, or diseases of lipid metabolism.
8. History of photosensitizing disorders.
9. Use of medications which interact with the study procedures according to the principal investigator (during or prior to the study).
10. Subjects currently participating in a study or who have participated in any other clinical studies during the last 3 months prior to the study
11. 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.
12. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
13. Immunocompromised subjects .
14. Woman who started Hormone Replacement Therapy within the last three months preceding the screening visit.
15. 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.

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Primary outcomes:
measure: Improves skin hydration
timeFrame: 16 weeks
measure: Improves skin smoothness and texture
timeFrame: 16 weeks
measure: Improves lines and wrinkles
timeFrame: 16 weeks
measure: Improves skin barrier function
timeFrame: 16 weeks
measure: Improves skin thickness and density
timeFrame: 16 weeks
measure: Increases dermal hemoglobin
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Port Chester
country: United States
facility: International Research Services, Inc.
state: New York
Study officials:
affiliation: IRSI
name: Robert Frumento, Phd
role: STUDY_DIRECTOR
References: