Clinical trial NCT04237818: The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Official title: The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin tone
timeFrame: Change from Baseline skin tone at 8 weeks
measure: The change of skin brightness
timeFrame: Change from Baseline skin brightness at 8 weeks
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 8 weeks
measure: The change of skin L*a*b* value
timeFrame: Change from Baseline skin L*a*b* value at 8 weeks
Secondary outcomes:
measure: The change of transepidermal water loss (TEWL)
timeFrame: Change from Baseline TEWL at 8 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 8 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 8 weeks
measure: The change of skin spots
timeFrame: Change from Baseline skin spots at 8 weeks
measure: The change of skin erythema level
timeFrame: Change from Baseline skin erythema level at 8 weeks
measure: Self-assessment questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Hsiu-Mei Chiang, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Po-Yuan Wu, Dr.
role: STUDY_DIRECTOR
References: