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

A 16-Week Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters in Healthy Female Subjects

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.

Study Overview

• Status: Completed
• Conditions: Skin Care
• Intervention / Treatment: Dietary supplement: Lycoderm; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Port Chester, New York, United States, 10573
      • International Research Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lycoderm; soft gel contains nutritional supplement	Dietary supplement: Lycoderm; soft gel contains nutritional supplement
PLACEBO_COMPARATOR: Placebo; Soft gel without active ingredients	Dietary supplement: Placebo; soft gel without active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improves skin hydration	instrumental evaluation (Corneometer)	16 weeks
Improves skin smoothness and texture	image analysis (Antera)	16 weeks
Improves lines and wrinkles	image analysis (Clarity)	16 weeks
Improves skin barrier function	instrumental evaluation (VapoMeter)	16 weeks
Improves skin thickness and density	instrumental evaluation (DermaScan Ultrasound)	16 weeks
Increases dermal hemoglobin	instrumental evaluation (SIAScope).	16 weeks

Collaborators and Investigators

• Sponsor: LycoRed Ltd.
• Investigators: Study Director: Robert Frumento, Phd, IRSI

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2017
• Primary Completion (ACTUAL): March 17, 2019
• Study Completion (ACTUAL): May 30, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 30, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4158LY0817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No