Back to resultsInvestigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors (Resveratrol)
Primary Purpose
Skin Conditions, Proinflammatory Cytokines
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Resveratrol drink
Placebo drink
Sponsored by
About this trial
This is an interventional prevention trial for Skin Conditions
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers aged above 20 years old
Exclusion Criteria:
- 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.
Sites / Locations
- Chia Nan University of Pharmacy & Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Resveratrol drink
Placebo drink
Arm Description
Outcomes
Primary Outcome Measures
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
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
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
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
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of total antioxidant capacity of blood
Total Antioxidant Capacity Assay Kit
The change of TNF-alpha of blood
ELISA Kit
The change of IL-6 of blood
ELISA Kit
The change of IL-17 of blood
ELISA Kit
The change of IL-1β of blood
ELISA Kit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04456829
Brief Title
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors
Acronym
Resveratrol
Official Title
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Conditions, Proinflammatory Cytokines
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resveratrol drink
Arm Type
Experimental
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol drink
Other Intervention Name(s)
Grape Yeast Compound Fruit Vegetable Beverage
Intervention Description
Subjects will consume a bottle of resveratrol drink for two months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Subjects will consume a bottle of placebo drink for two months.
Primary Outcome Measure Information:
Title
The change of skin moisture
Description
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
0, 4, and 8 weeks
Title
The change of skin elasticity
Description
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
Time Frame
0, 4, and 8 weeks
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Time Frame
0, 4, and 8 weeks
Title
The change of skin collagen density
Description
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:
Intensity score
Time Frame
0, 4, and 8 weeks
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
0, 4, and 8 weeks
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Time Frame
0, 4, and 8 weeks
Title
The change of total antioxidant capacity of blood
Description
Total Antioxidant Capacity Assay Kit
Time Frame
0 and 8 weeks
Title
The change of TNF-alpha of blood
Description
ELISA Kit
Time Frame
0 and 8 weeks
Title
The change of IL-6 of blood
Description
ELISA Kit
Time Frame
0 and 8 weeks
Title
The change of IL-17 of blood
Description
ELISA Kit
Time Frame
0 and 8 weeks
Title
The change of IL-1β of blood
Description
ELISA Kit
Time Frame
0 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers aged above 20 years old
Exclusion Criteria:
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.
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan City
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors
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