Back to resultsThe Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Primary Purpose
Skin Condition
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged between 20-65 years old
- Subjects must read and sign the informed consent form after the study has been fully explained.
- Subjects are willing to cooperate and comply with all of the regulation during the trial.
- Subject should inform to investigator immediately if adverse effect is happened.
- Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment).
Exclusion Criteria:
- Subjects who have known cosmetic, drug or food allergies.
- Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement.
- Subjects with any physical condition judged by the researcher not to be eligible for this study.
- Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago.
- Women who have started contraceptive or change current hormone contraceptive methods within 3 months.
Sites / Locations
- China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Arm Description
Outcomes
Primary Outcome Measures
The change of skin moisture
Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin elasticity
Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
The change of skin wrinkles
3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units
The change of skin collagen density
DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score
The change of skin tone
3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units
The change of skin brightness
3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units
The change of skin melanin index
Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
The change of skin L*a*b* value
Color Spectrophotometer SCM-104/108 is utilized to measure skin L*a*b* value. Units: arbitrary units
Secondary Outcome Measures
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²
The change of skin texture
3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units
The change of skin pores
3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units
The change of skin spots
3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units
The change of skin erythema level
Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999)
Self-assessment questionnaire
Questionnaire is utilized to assess skin condition of the subjects. Units: score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04237818
Brief Title
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Official Title
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
August 15, 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
5. Study Description
Brief Summary
To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 2 bottle (30 mL) per day for 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Intervention Description
consume 2 bottle (30 mL) per day for 56 days
Primary Outcome Measure Information:
Title
The change of skin moisture
Description
Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
Change from Baseline skin moisture at 8 weeks
Title
The change of skin elasticity
Description
Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
Time Frame
Change from Baseline skin elasticity at 8 weeks
Title
The change of skin wrinkles
Description
3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 8 weeks
Title
The change of skin collagen density
Description
DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score
Time Frame
Change from Baseline skin collagen density at 8 weeks
Title
The change of skin tone
Description
3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units
Time Frame
Change from Baseline skin tone at 8 weeks
Title
The change of skin brightness
Description
3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units
Time Frame
Change from Baseline skin brightness at 8 weeks
Title
The change of skin melanin index
Description
Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
Time Frame
Change from Baseline skin melanin index at 8 weeks
Title
The change of skin L*a*b* value
Description
Color Spectrophotometer SCM-104/108 is utilized to measure skin L*a*b* value. Units: arbitrary units
Time Frame
Change from Baseline skin L*a*b* value at 8 weeks
Secondary Outcome Measure Information:
Title
The change of transepidermal water loss (TEWL)
Description
Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²
Time Frame
Change from Baseline TEWL at 8 weeks
Title
The change of skin texture
Description
3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 8 weeks
Title
The change of skin pores
Description
3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin pores at 8 weeks
Title
The change of skin spots
Description
3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units
Time Frame
Change from Baseline skin spots at 8 weeks
Title
The change of skin erythema level
Description
Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999)
Time Frame
Change from Baseline skin erythema level at 8 weeks
Title
Self-assessment questionnaire
Description
Questionnaire is utilized to assess skin condition of the subjects. Units: score
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged between 20-65 years old
Subjects must read and sign the informed consent form after the study has been fully explained.
Subjects are willing to cooperate and comply with all of the regulation during the trial.
Subject should inform to investigator immediately if adverse effect is happened.
Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment).
Exclusion Criteria:
Subjects who have known cosmetic, drug or food allergies.
Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement.
Subjects with any physical condition judged by the researcher not to be eligible for this study.
Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc.
Female who is pregnant or nursing or planning to become pregnant during the course of the study.
Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago.
Women who have started contraceptive or change current hormone contraceptive methods within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Mei Chiang, Prof.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Po-Yuan Wu, Dr.
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
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