Efficacy Evaluation of Wasabi Leaf Extract on Skin

Skin Condition Clinical Trial

Official title:

Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310994
• Other study ID #: CMUH111-REC3-028
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of Wasabi Leaf Extract on skin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle per day
• Wasabi Leaf Extract Drink
consume 1 bottle per day

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)	Change from Baseline skin melanin index at 8 weeks
Primary	The change of skin erythema index	Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)	Change from Baseline skin erythema index at 8 weeks
Primary	The change of skin sebum content	Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350	Change from Baseline skin sebum content at 8 weeks
Primary	The change of transepidermal water loss	Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²	Change from Baseline TEWL at 8 weeks
Primary	The change of L* (lightness) values	Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units	Change from Baseline L* value at 8 weeks
Primary	The change of a* (redness) values	Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units	Change from Baseline a* value at 8 weeks
Primary	The change of visible spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Change from Baseline visible spots at 8 weeks
Primary	The change of skin red area	VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units	Change from Baseline skin red area at 8 weeks
Primary	The change of total antioxidant capacity of blood	Venous blood was sampled to measure total antioxidant capacity	Change from Baseline total antioxidant capacity at 8 weeks
Primary	The change of Interleukin-6 of blood	Venous blood was sampled to measure IL-6	Change from Baseline IL-6 at 8 weeks
Primary	The change of Interleukin-8 of blood	Venous blood was sampled to measure IL-8	Change from Baseline IL-8 at 8 weeks
Primary	The change of Insulin-Like Growth Factor-1 of blood	Venous blood was sampled to measure IGF-1	Change from Baseline IGF-1 at 8 weeks
Secondary	The change of skin hydration	Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary	Change from Baseline skin hydration at 8 weeks
Secondary	The change of UV spots	VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units	Change from Baseline UV spots at 8 weeks
Secondary	The change of brown spots	VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units	Change from Baseline brown spots at 8 weeks
Secondary	The change of Advanced glycation end products of blood	Venous blood was sampled to measure AGEs	Change from Baseline AGEs at 8 weeks
Secondary	The change of liver function biomarkers (AST, ALT) of blood	Venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
Secondary	The change of renal function biomarkers (creatinine, BUN) of blood	Venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
Secondary	The change of fasting blood glugose level	Venous blood was sampled to measure fasting blood glugose level	Change from Baseline fasting blood glugose level at 8 weeks
Secondary	The change of blood lipid profile	Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)	Change from Baseline blood lipid profile at 8 weeks