Skin CareLycodermNCT03402373
Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters
A study testing Lycoderm in people with Skin Care, run by LycoRed Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Lycoderm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
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Trial locations and contacts
1 site in 1 country.
United States1 site
International Research Services, Inc.
Port Chester, New York, 10573
About this study
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
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.
Read the 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
- Being tested
- Lycoderm, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycodermDietary supplement
soft gel contains nutritional supplement
PlaceboDietary supplement
soft gel without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Lycoderm | Experimental | soft gel contains nutritional supplement Receives: Dietary Supplement: Lycoderm |
| Placebo | Placebo comparator | Soft gel without active ingredients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improves skin hydration
instrumental evaluation (Corneometer)
Measured: 16 weeks
Improves skin smoothness and texture
image analysis (Antera)
Measured: 16 weeks
Improves lines and wrinkles
image analysis (Clarity)
Measured: 16 weeks
Improves skin barrier function
instrumental evaluation (VapoMeter)
Measured: 16 weeks
Improves skin thickness and density
instrumental evaluation (DermaScan Ultrasound)
Measured: 16 weeks
Increases dermal hemoglobin
instrumental evaluation (SIAScope).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start17 Nov 2017
- Primary completion17 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, Randomized, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Frumento, Phd, Study director, IRSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402373
- Sponsor's protocol ID
- 4158LY0817
- Acronym
- Lycoderm
- Status last verified
- Jun 2019
- First submitted
- 21 Dec 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03402373
- Acronym / sponsor ID
- Lycoderm / 4158LY0817
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind, Randomized, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Lycoderm | Experimental | Dietary Supplement: Lycodermsoft gel contains nutritional supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoft gel without active ingredients |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycodermsoft gel contains nutritional supplement | Dietary supplement | Lycoderm |
| Placebosoft gel without active ingredients | Dietary supplement | Placebo |
Primary outcome
Improves skin hydration
Time frame: 16 weeks
instrumental evaluation (Corneometer)
Improves skin smoothness and texture
Time frame: 16 weeks
image analysis (Antera)
Improves lines and wrinkles
Time frame: 16 weeks
image analysis (Clarity)
Improves skin barrier function
Time frame: 16 weeks
instrumental evaluation (VapoMeter)
Improves skin thickness and density
Time frame: 16 weeks
instrumental evaluation (DermaScan Ultrasound)
Increases dermal hemoglobin
Time frame: 16 weeks
instrumental evaluation (SIAScope).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Frumento, Phd study director
IRSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycoderm in people with Skin Care, run by LycoRed Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improves skin hydration (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.