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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04237818
Other study ID # CMUH108-REC1-147
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date August 15, 2020

Study information

Verified date January 2020
Source TCI Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 15, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo drink
consume 2 bottle (30 mL) per day for 56 days
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
consume 2 bottle (30 mL) per day for 56 days

Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of skin moisture Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120 Change from Baseline skin moisture at 8 weeks
Primary 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 Change from Baseline skin elasticity at 8 weeks
Primary The change of skin wrinkles 3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units Change from Baseline skin wrinkles at 8 weeks
Primary 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 Change from Baseline skin collagen density at 8 weeks
Primary The change of skin tone 3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units Change from Baseline skin tone at 8 weeks
Primary The change of skin brightness 3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units Change from Baseline skin brightness at 8 weeks
Primary The change of skin melanin index Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999) Change from Baseline skin melanin index at 8 weeks
Primary 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 Change from Baseline skin L*a*b* value at 8 weeks
Secondary The change of transepidermal water loss (TEWL) Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm² Change from Baseline TEWL at 8 weeks
Secondary The change of skin texture 3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units Change from Baseline skin texture at 8 weeks
Secondary The change of skin pores 3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units Change from Baseline skin pores at 8 weeks
Secondary The change of skin spots 3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units Change from Baseline skin spots at 8 weeks
Secondary The change of skin erythema level Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999) Change from Baseline skin erythema level at 8 weeks
Secondary Self-assessment questionnaire Questionnaire is utilized to assess skin condition of the subjects. Units: score 8 weeks
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