Skin ConditionNCT05310994
Efficacy Evaluation of Wasabi Leaf Extract on Skin
A study testing Wasabi Leaf Extract Drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of Wasabi Leaf Extract on skin 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?
- Wasabi Leaf Extract Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2022to 31 Jul 2022
- 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
- 20 to 65-year-old males or females
- People with dull skin, pigmentation spots or acne-prone, acne scars
- Acne severity assessment- Investigator's Global Assessment Scale (IGA) ≥ 2
Who cannot join
- Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
- Outdoor workers (exposed to the sun more than 5 hours a day)
- People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
- People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
- People who have undergone major surgery (according to medical history)
- People who take drugs for a long time
- People with mental illness
- Students who are currently taking courses taught by the principal investigator of this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin
To assess the efficacy of Wasabi Leaf Extract on skin
- Conditions
- Skin Condition
- Being tested
- Placebo drink, Wasabi Leaf 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 1 bottle per day
Wasabi Leaf Extract DrinkDietary supplement
Also called Wasabi (Wasabia japonica) leaf extract drink
consume 1 bottle per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
| Wasabi Leaf Extract Drink | Experimental | Not described Receives: Dietary Supplement: Wasabi Leaf Extract Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin melanin index
Mexameter® MX18 was 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 erythema index
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)
Measured: Change from Baseline skin erythema index at 8 weeks
The change of skin sebum content
Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350
Measured: Change from Baseline skin sebum content at 8 weeks
The change of transepidermal water loss
Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²
Measured: Change from Baseline TEWL at 8 weeks
The change of L* (lightness) values
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
Measured: Change from Baseline L* value at 8 weeks
The change of a* (redness) values
Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units
Measured: Change from Baseline a* value at 8 weeks
The change of visible spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Measured: Change from Baseline visible spots at 8 weeks
The change of skin red area
VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units
Measured: Change from Baseline skin red area at 8 weeks
The change of total antioxidant capacity of blood
Venous blood was sampled to measure total antioxidant capacity
Measured: Change from Baseline total antioxidant capacity at 8 weeks
The change of Interleukin-6 of blood
Venous blood was sampled to measure IL-6
Measured: Change from Baseline IL-6 at 8 weeks
The change of Interleukin-8 of blood
Venous blood was sampled to measure IL-8
Measured: Change from Baseline IL-8 at 8 weeks
The change of Insulin-Like Growth Factor-1 of blood
Venous blood was sampled to measure IGF-1
Measured: Change from Baseline IGF-1 at 8 weeks
Secondary outcomes (8)
The change of skin hydration
Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary
Measured: Change from Baseline skin hydration at 8 weeks
The change of UV spots
VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units
Measured: Change from Baseline UV spots at 8 weeks
The change of brown spots
VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units
Measured: Change from Baseline brown spots at 8 weeks
The change of Advanced glycation end products of blood
Venous blood was sampled to measure AGEs
Measured: Change from Baseline AGEs at 8 weeks
The change of liver function biomarkers (AST, ALT) of blood
Venous blood was sampled to measure liver function biomarkers
Measured: Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood
Venous blood was sampled to measure renal function biomarkers
Measured: Change from Baseline renal function biomarkers at 8 weeks
The change of fasting blood glugose level
Venous blood was sampled to measure fasting blood glugose level
Measured: Change from Baseline fasting blood glugose level at 8 weeks
The change of blood lipid profile
Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
Measured: Change from Baseline blood lipid profile at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start28 Mar 2022
- Primary completion15 Jun 2022
- Study completion31 Jul 2022
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
- NCT05310994
- Sponsor's protocol ID
- CMUH111-REC3-028
- Status last verified
- Sep 2022
- First submitted
- 28 Mar 2022
- Last updated
- 29 Sep 2022
- 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 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin
- ClinicalTrials.gov ID
- NCT05310994
- Acronym / sponsor ID
- CMUH111-REC3-028
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 5 Apr 2022 (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 the efficacy of Wasabi Leaf Extract on skin
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 |
| Wasabi Leaf Extract Drink | Experimental | Dietary Supplement: Wasabi Leaf Extract Drink |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 65-year-old males or females
- People with dull skin, pigmentation spots or acne-prone, acne scars
- Acne severity assessment- Investigator's Global Assessment Scale (IGA) ≥ 2
Key exclusion criteria (8 listed)
- Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
- Outdoor workers (exposed to the sun more than 5 hours a day)
- People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
- People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
- People who have undergone major surgery (according to medical history)
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 1 bottle per day | Dietary supplement | Placebo drink |
| Wasabi Leaf Extract DrinkAlso: Wasabi (Wasabia japonica) leaf extract drinkconsume 1 bottle per day | Dietary supplement | Wasabi Leaf Extract Drink |
Primary outcome
The change of skin melanin index
Time frame: Change from Baseline skin melanin index at 8 weeks
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
The change of skin erythema index
Time frame: Change from Baseline skin erythema index at 8 weeks
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)
The change of skin sebum content
Time frame: Change from Baseline skin sebum content at 8 weeks
Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350
The change of transepidermal water loss
Time frame: Change from Baseline TEWL at 8 weeks
Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²
The change of L* (lightness) values
Time frame: Change from Baseline L* value at 8 weeks
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
The change of a* (redness) values
Time frame: Change from Baseline a* value at 8 weeks
Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units
The change of visible spots
Time frame: Change from Baseline visible spots at 8 weeks
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of skin red area
Time frame: Change from Baseline skin red area at 8 weeks
VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units
The change of total antioxidant capacity of blood
Time frame: Change from Baseline total antioxidant capacity at 8 weeks
Venous blood was sampled to measure total antioxidant capacity
The change of Interleukin-6 of blood
Time frame: Change from Baseline IL-6 at 8 weeks
Venous blood was sampled to measure IL-6
The change of Interleukin-8 of blood
Time frame: Change from Baseline IL-8 at 8 weeks
Venous blood was sampled to measure IL-8
The change of Insulin-Like Growth Factor-1 of blood
Time frame: Change from Baseline IGF-1 at 8 weeks
Venous blood was sampled to measure IGF-1
8 secondary outcomes
The change of skin hydration
Time frame: Change from Baseline skin hydration at 8 weeks
The change of UV spots
Time frame: Change from Baseline UV spots at 8 weeks
The change of brown spots
Time frame: Change from Baseline brown spots at 8 weeks
The change of Advanced glycation end products of blood
Time frame: Change from Baseline AGEs at 8 weeks
The change of liver function biomarkers (AST, ALT) of blood
Time frame: Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood
Time frame: Change from Baseline renal function biomarkers at 8 weeks
The change of fasting blood glugose level
Time frame: Change from Baseline fasting blood glugose level at 8 weeks
The change of blood lipid profile
Time frame: Change from Baseline blood lipid profile at 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 29 Sep 2022.
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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 Wasabi Leaf 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 3 inclusion and 8 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 29 Sep 2022. 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 melanin index (time frame: Change from Baseline skin melanin index at 8 weeks). The study lists 12 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 29 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.