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

NCT04237818 | Completed

• 1 other identifier: CMUH108-REC1-147
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• The change of transepidermal water loss (TEWL)

  Change from Baseline TEWL at 8 weeks

• The change of skin texture

  Change from Baseline skin texture at 8 weeks

• The change of skin pores

  Change from Baseline skin pores at 8 weeks

• The change of skin spots

  Change from Baseline skin spots at 8 weeks

• The change of skin erythema level

  Change from Baseline skin erythema level at 8 weeks

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

EXPERIMENTAL

Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 2 bottle (30 mL) per day for 56 days

Placebo drink

Chenopodium Formosanum and Fagopyrum Esculentum Extract drink DIETARY_SUPPLEMENT

consume 2 bottle (30 mL) per day for 56 days

Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Hsiu-Mei Chiang, Prof.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

• Po-Yuan Wu, Dr.

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: February 1, 2020
• Primary Completion: April 30, 2020
• Study Completion: August 15, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-01

Locations

TW (1)