Skin ConditionsResveratrolNCT04456829
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors
A study testing Resveratrol drink in people with Skin Conditions and Proinflammatory Cytokines, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Conditions, Proinflammatory Cytokines
- What is being tested?
- Resveratrol drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2020to 31 Dec 2020
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged above 20 years old
Who cannot join
- Subject who is not willing to participate in this study.
- Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
- Subjects who have large spots (area >3 square centimeter) or abnormal acne.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin
To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood
- Conditions
- Skin Conditions, Proinflammatory Cytokines
- Being tested
- Resveratrol drink, Placebo drink
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol drinkDietary supplement
Also called Grape Yeast Compound Fruit Vegetable Beverage
Subjects will consume a bottle of resveratrol drink for two months.
Placebo drinkDietary supplement
Subjects will consume a bottle of placebo drink for two months.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol drink | Experimental | Not described Receives: Dietary Supplement: Resveratrol drink |
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Measured: 0, 4, and 8 weeks
The change of skin elasticity
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
Measured: 0, 4, and 8 weeks
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Measured: 0, 4, and 8 weeks
The change of skin collagen density
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:
Intensity score
Measured: 0, 4, and 8 weeks
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: 0, 4, and 8 weeks
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Measured: 0, 4, and 8 weeks
The change of total antioxidant capacity of blood
Total Antioxidant Capacity Assay Kit
Measured: 0 and 8 weeks
The change of TNF-alpha of blood
ELISA Kit
Measured: 0 and 8 weeks
The change of IL-6 of blood
ELISA Kit
Measured: 0 and 8 weeks
The change of IL-17 of blood
ELISA Kit
Measured: 0 and 8 weeks
The change of IL-1β of blood
ELISA Kit
Measured: 0 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start17 Sep 2020
- Primary completion10 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456829
- Sponsor's protocol ID
- 20-0-54-B
- Acronym
- Resveratrol
- Status last verified
- Jan 2021
- First submitted
- 30 Jun 2020
- Last updated
- 15 Jan 2021
- 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 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin
- ClinicalTrials.gov ID
- NCT04456829
- Acronym / sponsor ID
- Resveratrol / 20-0-54-B
- Conditions
- Skin Conditions, Proinflammatory Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jul 2020 (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.
To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol drink | Experimental | Dietary Supplement: Resveratrol drink |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers aged above 20 years old
Key exclusion criteria (6 listed)
- Subject who is not willing to participate in this study.
- Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
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 |
|---|---|---|
| Resveratrol drinkAlso: Grape Yeast Compound Fruit Vegetable BeverageSubjects will consume a bottle of resveratrol drink for two months. | Dietary supplement | Resveratrol drink |
| Placebo drinkSubjects will consume a bottle of placebo drink for two months. | Dietary supplement | Placebo drink |
Primary outcome
The change of skin moisture
Time frame: 0, 4, and 8 weeks
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin elasticity
Time frame: 0, 4, and 8 weeks
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
The change of skin wrinkles
Time frame: 0, 4, and 8 weeks
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
The change of skin collagen density
Time frame: 0, 4, and 8 weeks
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score
The change of skin texture
Time frame: 0, 4, and 8 weeks
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
Time frame: 0, 4, and 8 weeks
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of total antioxidant capacity of blood
Time frame: 0 and 8 weeks
Total Antioxidant Capacity Assay Kit
The change of TNF-alpha of blood
Time frame: 0 and 8 weeks
ELISA Kit
The change of IL-6 of blood
Time frame: 0 and 8 weeks
ELISA Kit
The change of IL-17 of blood
Time frame: 0 and 8 weeks
ELISA Kit
The change of IL-1β of blood
Time frame: 0 and 8 weeks
ELISA Kit
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 15 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol drink in people with Skin Conditions and Proinflammatory Cytokines, run by TCI Co., Ltd. at 1 site in Taiwan.
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 1 inclusion and 6 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 15 Jan 2021. 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 Taiwan. 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?
The change of skin moisture (time frame: 0, 4, and 8 weeks). The study lists 11 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 15 Jan 2021.