Back to resultsEfficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
Primary Purpose
Skin Condition
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chenopodium formosanum extracts sachet
Placebo sachet
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged above 20 years old
Exclusion Criteria:
- Subject who is not willing to participate in this study.
- Patients with diseases of the skin, liver, kidney.
- 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 (> 3 hr/week) in the past 4 weeks.
- Constant drug use
- Students who are currently taking courses taught by the principal investigator of this trial.
Sites / Locations
- Chia Nan University of Pharmacy & ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo sachet
Chenopodium formosanum extracts sachet
Arm Description
consume 1 sachet per day
consume 1 sachet per day
Outcomes
Primary Outcome Measures
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of skin elasticity
Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units
Secondary Outcome Measures
The change of skin melanin index
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
The change of skin erythema index
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of AGEs of blood
Fasting venous blood was sampled to measure concentrations of AGEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05591352
Brief Title
Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
Official Title
Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
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 extracts on skin condition improvement
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
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo sachet
Arm Type
Placebo Comparator
Arm Description
consume 1 sachet per day
Arm Title
Chenopodium formosanum extracts sachet
Arm Type
Experimental
Arm Description
consume 1 sachet per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Chenopodium formosanum extracts sachet
Other Intervention Name(s)
Formosa Ruby sachet
Intervention Description
consume 1 sachet per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo sachet
Intervention Description
consume 1 sachet per day
Primary Outcome Measure Information:
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 8 weeks
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 8 weeks
Title
The change of skin collagen density
Description
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin collagen density at 8 weeks
Title
The change of skin elasticity
Description
Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Change from Baseline skin elasticity at 8 weeks
Secondary Outcome Measure Information:
Title
The change of skin melanin index
Description
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
Time Frame
Change from Baseline skin melanin index at 8 weeks
Title
The change of skin L* value
Description
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Time Frame
Change from Baseline L* value at 8 weeks
Title
The change of skin erythema index
Description
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
Time Frame
Change from Baseline skin erythema index at 8 weeks
Title
The change of skin moisture
Description
Corneometer® CM825 was 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 transepidermal water loss (TEWL)
Description
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
Time Frame
Change from Baseline TEWL at 8 weeks
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin pores at 8 weeks
Title
The change of AGEs of blood
Description
Fasting venous blood was sampled to measure concentrations of AGEs
Time Frame
Change from Baseline AGEs at 8 weeks
Other Pre-specified Outcome Measures:
Title
The change of liver function biomarkers (AST, ALT) of blood
Description
Fasting venous blood was sampled to measure liver function biomarkers
Time Frame
Change from Baseline liver function biomarkers at 8 weeks
Title
The change of renal function biomarkers (creatinine, BUN) of blood
Description
Fasting venous blood was sampled to measure renal function biomarkers
Time Frame
Change from Baseline renal function biomarkers at 8 weeks
Title
The change of self-assessment skin condition
Description
A self-assessment questionnaire was collected to evaluate skin condition
Time Frame
Change from Baseline skin condition at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged above 20 years old
Exclusion Criteria:
Subject who is not willing to participate in this study.
Patients with diseases of the skin, liver, kidney.
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 (> 3 hr/week) in the past 4 weeks.
Constant drug use
Students who are currently taking courses taught by the principal investigator of this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hua Liang
Phone
+886-06-2661911
Ext
2441
Email
tinna_ling@mail.cnu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Lin
Phone
+886-02-87977811
Email
candice.lin@tci-bio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan City
ZIP/Postal Code
71710
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, Ph.D.
Phone
886-6-2664911
Ext
2441
Email
tinna_ling@mail.cnu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty
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