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

NCT03402373 | Completed

• 1 other identifier: 4158LY0817
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Lycoderm

EXPERIMENTAL

soft gel contains nutritional supplement

Dietary Supplement: Lycoderm

Placebo

PLACEBO COMPARATOR

Soft gel without active ingredients

Dietary Supplement: Placebo

Interventions

Lycoderm DIETARY_SUPPLEMENT

soft gel contains nutritional supplement

Lycoderm

Placebo DIETARY_SUPPLEMENT

soft gel without active ingredients

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• LycoRed Ltd.: lead

Study Sites (1)

International Research Services, Inc.

Port Chester, New York, 10573, United States

Location

Study Officials

• Robert Frumento, Phd

  IRSI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind, Randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blind, Randomized, Placebo-Controlled

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 18, 2018
• Study Start: November 17, 2017
• Primary Completion: March 17, 2019
• Study Completion: May 30, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)