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

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

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; consume 2 bottle (30 mL) per day for 56 days
Experimental: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink	Dietary supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink; consume 2 bottle (30 mL) per day for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Self-assessment questionnaire	Questionnaire is utilized to assess skin condition of the subjects. Units: score	8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CMUH108-REC1-147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No