Efficacy Evaluation of Wasabi Leaf Extract on Skin

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

To assess the efficacy of Wasabi Leaf Extract on skin

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Wasabi Leaf Extract Drink

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; consume 1 bottle per day
Experimental: Wasabi Leaf Extract Drink	Dietary supplement: Wasabi Leaf Extract Drink; consume 1 bottle per day; Other Names: Wasabi (Wasabia japonica) leaf extract drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
The change of Interleukin-6 of blood	Venous blood was sampled to measure IL-6	Change from Baseline IL-6 at 8 weeks
The change of Interleukin-8 of blood	Venous blood was sampled to measure IL-8	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	Change from Baseline IGF-1 at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Advanced glycation end products of blood	Venous blood was sampled to measure AGEs	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	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	Change from Baseline renal function biomarkers 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)	Change from Baseline blood lipid profile at 8 weeks
The change of skin hydration	Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary	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	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	Change from Baseline brown spots at 8 weeks
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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CMUH111-REC3-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No