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Completed

NCT Number: NCT04237818

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

Completed

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Key information

Conditions

Skin Condition Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo drink

Dietary Supplement

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

Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

Dietary Supplement

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

Primary outcomes

  1. The change of skin moisture

    Time frame: Change from Baseline skin moisture at 8 weeks

    Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

  2. The change of skin elasticity

    Time frame: 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

  3. The change of skin wrinkles

    Time frame: Change from Baseline skin wrinkles at 8 weeks

    3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units

  4. The change of skin collagen density

    Time frame: 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

  5. The change of skin tone

    Time frame: Change from Baseline skin tone at 8 weeks

    3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units

  6. The change of skin brightness

    Time frame: Change from Baseline skin brightness at 8 weeks

    3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units

  7. The change of skin melanin index

    Time frame: 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)

  8. The change of skin L*a*b* value

    Time frame: 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

Secondary outcomes

  1. The change of transepidermal water loss (TEWL)

    Time frame: Change from Baseline TEWL at 8 weeks

    Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²

  2. The change of skin texture

    Time frame: Change from Baseline skin texture at 8 weeks

    3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units

  3. The change of skin pores

    Time frame: Change from Baseline skin pores at 8 weeks

    3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units

  4. The change of skin spots

    Time frame: Change from Baseline skin spots at 8 weeks

    3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units

  5. The change of skin erythema level

    Time frame: 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)

  6. Self-assessment questionnaire

    Time frame: 8 weeks

    Questionnaire is utilized to assess skin condition of the subjects. Units: score

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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