Skin ConditionNCT04237818
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
A study testing Chenopodium Formosanum and Fagopyrum Esculentum Extract drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging
- Conditions
- Skin Condition
- Being tested
- Placebo drink, Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 2 bottle (30 mL) per day for 56 days
Chenopodium Formosanum and Fagopyrum Esculentum Extract drinkDietary supplement
consume 2 bottle (30 mL) per day for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
| Chenopodium Formosanum and Fagopyrum Esculentum Extract drink | Experimental | Not described Receives: Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin moisture
Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Change from Baseline skin L*a*b* value at 8 weeks
Secondary outcomes (6)
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm²
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Change from Baseline skin erythema level at 8 weeks
Self-assessment questionnaire
Questionnaire is utilized to assess skin condition of the subjects. Units: score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Apr 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiu-Mei Chiang, Prof., Principal investigator, China Medical University, ChinaPo-Yuan Wu, Dr., Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237818
- Sponsor's protocol ID
- CMUH108-REC1-147
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
- ClinicalTrials.gov ID
- NCT04237818
- Acronym / sponsor ID
- CMUH108-REC1-147
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo drinkconsume 2 bottle (30 mL) per day for 56 days | Dietary supplement | Placebo drink |
| Chenopodium Formosanum and Fagopyrum Esculentum Extract drinkconsume 2 bottle (30 mL) per day for 56 days | Dietary supplement | Chenopodium Formosanum and Fagopyrum Esculentum Extract drink |
Primary outcome
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
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
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
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
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
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
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)
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
6 secondary outcomes
The change of transepidermal water loss (TEWL)
Time frame: Change from Baseline TEWL at 8 weeks
The change of skin texture
Time frame: Change from Baseline skin texture at 8 weeks
The change of skin pores
Time frame: Change from Baseline skin pores at 8 weeks
The change of skin spots
Time frame: Change from Baseline skin spots at 8 weeks
The change of skin erythema level
Time frame: Change from Baseline skin erythema level at 8 weeks
Self-assessment questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Mei Chiang, Prof. principal investigator
China Medical University, China
Po-Yuan Wu, Dr. study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chenopodium Formosanum and Fagopyrum Esculentum Extract drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of skin moisture (time frame: Change from Baseline skin moisture at 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.