The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

Skin Condition Clinical Trial

Official title:

The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237818
• Other study ID #: CMUH108-REC1-147
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

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