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

Not Applicable

Completed

• Conditions: Skin Condition
• Interventions: Dietary Supplement: Placebo drink; Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

• Registration Number: NCT04237818
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Study Start: 2020-02-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-08-15
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drink	Placebo drink	-
Chenopodium Formosanum and Fagopyrum Esculentum Extract drink	Chenopodium Formosanum and Fagopyrum Esculentum Extract drink	-

Primary Outcome Measures

Name	Time	Method
The change of skin elasticity	Change from Baseline skin elasticity at 8 weeks	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	Change from Baseline skin wrinkles at 8 weeks	3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units
The change of skin moisture	Change from Baseline skin moisture at 8 weeks	Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin collagen density	Change from Baseline skin collagen density at 8 weeks	DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score
The change of skin melanin index	Change from Baseline skin melanin index at 8 weeks	Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
The change of skin brightness	Change from Baseline skin brightness at 8 weeks	3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units
The change of skin L*a*b* value	Change from Baseline skin L*a*b* value at 8 weeks	Color Spectrophotometer SCM-104/108 is utilized to measure skin L\*a\*b\* value. Units: arbitrary units
The change of skin tone	Change from Baseline skin tone at 8 weeks	3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units

Secondary Outcome Measures

Name	Time	Method
The change of transepidermal water loss (TEWL)	Change from Baseline TEWL at 8 weeks	Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²
The change of skin texture	Change from Baseline skin texture at 8 weeks	3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units
The change of skin spots	Change from Baseline skin spots at 8 weeks	3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units
The change of skin erythema level	Change from Baseline skin erythema level at 8 weeks	Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999)
The change of skin pores	Change from Baseline skin pores at 8 weeks	3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units
Self-assessment questionnaire	8 weeks	Questionnaire is utilized to assess skin condition of the subjects. Units: score

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan