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

NCT ID: NCT03402373

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2019-05-30

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.

Conditions

Skin Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Lycoderm

soft gel contains nutritional supplement

Group Type: EXPERIMENTAL

Lycoderm

Intervention Type: DIETARY_SUPPLEMENT

soft gel contains nutritional supplement

Placebo

Soft gel without active ingredients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

soft gel without active ingredients

Interventions

Lycoderm

soft gel contains nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

soft gel without active ingredients

Intervention Type: DIETARY_SUPPLEMENT

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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• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

LycoRed Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Frumento, Phd

Role: STUDY_DIRECTOR

IRSI

Locations

International Research Services, Inc.

Port Chester, New York, United States

Countries

United States

Other Identifiers

4158LY0817

Identifier Type: -

Identifier Source: org_study_id