Efficacy Evaluation of Wasabi Leaf Extract on Skin

Not Applicable

Completed

• Conditions: Skin Condition
• Interventions: Dietary Supplement: Wasabi Leaf Extract Drink; Dietary Supplement: Placebo drink

• Registration Number: NCT05310994
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess the efficacy of Wasabi Leaf Extract on skin

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Primary Completion: 2022-06-15
• Study Completion: 2022-07-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wasabi Leaf Extract Drink	Wasabi Leaf Extract Drink	-
Placebo drink	Placebo drink	-

Primary Outcome Measures

Name	Time	Method
The change of transepidermal water loss	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 skin sebum content	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 skin erythema index	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 melanin index	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 a* (redness) values	Change from Baseline a* value at 8 weeks	Spectrophotometer SCM-108 was utilized to measure skin a\* value. Units: arbitrary units
The change of skin red area	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	Change from Baseline total antioxidant capacity at 8 weeks	Venous blood was sampled to measure total antioxidant capacity
The change of Interleukin-8 of blood	Change from Baseline IL-8 at 8 weeks	Venous blood was sampled to measure IL-8
The change of Interleukin-6 of blood	Change from Baseline IL-6 at 8 weeks	Venous blood was sampled to measure IL-6
The change of Insulin-Like Growth Factor-1 of blood	Change from Baseline IGF-1 at 8 weeks	Venous blood was sampled to measure IGF-1
The change of L* (lightness) values	Change from Baseline L* value at 8 weeks	Spectrophotometer SCM-108 was utilized to measure skin L\* value. Units: arbitrary units
The change of visible spots	Change from Baseline visible spots at 8 weeks	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units

Secondary Outcome Measures

Name	Time	Method
The change of fasting blood glugose level	Change from Baseline fasting blood glugose level at 8 weeks	Venous blood was sampled to measure fasting blood glugose level
The change of renal function biomarkers (creatinine, BUN) of blood	Change from Baseline renal function biomarkers at 8 weeks	Venous blood was sampled to measure renal function biomarkers
The change of Advanced glycation end products of blood	Change from Baseline AGEs at 8 weeks	Venous blood was sampled to measure AGEs
The change of UV spots	Change from Baseline UV spots at 8 weeks	VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units
The change of blood lipid profile	Change from Baseline blood lipid profile at 8 weeks	Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
The change of skin hydration	Change from Baseline skin hydration at 8 weeks	Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary
The change of brown spots	Change from Baseline brown spots at 8 weeks	VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units
The change of liver function biomarkers (AST, ALT) of blood	Change from Baseline liver function biomarkers at 8 weeks	Venous blood was sampled to measure liver function biomarkers

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan