Clinical trial NCT05310994: Efficacy Evaluation of Wasabi Leaf Extract on Skin
Official title: Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-05
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 the efficacy of Wasabi Leaf Extract on skin


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 8 weeks
measure: The change of skin erythema index
timeFrame: Change from Baseline skin erythema index at 8 weeks
measure: The change of skin sebum content
timeFrame: Change from Baseline skin sebum content at 8 weeks
measure: The change of transepidermal water loss
timeFrame: Change from Baseline TEWL at 8 weeks
measure: The change of L* (lightness) values
timeFrame: Change from Baseline L* value at 8 weeks
measure: The change of a* (redness) values
timeFrame: Change from Baseline a* value at 8 weeks
measure: The change of visible spots
timeFrame: Change from Baseline visible spots at 8 weeks
measure: The change of skin red area
timeFrame: Change from Baseline skin red area at 8 weeks
measure: The change of total antioxidant capacity of blood
timeFrame: Change from Baseline total antioxidant capacity at 8 weeks
measure: The change of Interleukin-6 of blood
timeFrame: Change from Baseline IL-6 at 8 weeks
measure: The change of Interleukin-8 of blood
timeFrame: Change from Baseline IL-8 at 8 weeks
measure: The change of Insulin-Like Growth Factor-1 of blood
timeFrame: Change from Baseline IGF-1 at 8 weeks
Secondary outcomes:
measure: The change of skin hydration
timeFrame: Change from Baseline skin hydration at 8 weeks
measure: The change of UV spots
timeFrame: Change from Baseline UV spots at 8 weeks
measure: The change of brown spots
timeFrame: Change from Baseline brown spots at 8 weeks
measure: The change of Advanced glycation end products of blood
timeFrame: Change from Baseline AGEs at 8 weeks
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: Change from Baseline liver function biomarkers at 8 weeks
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Change from Baseline renal function biomarkers at 8 weeks
measure: The change of fasting blood glugose level
timeFrame: Change from Baseline fasting blood glugose level at 8 weeks
measure: The change of blood lipid profile
timeFrame: Change from Baseline blood lipid profile at 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: