Efficacy Evaluation of Wasabi Leaf Extract on Skin

NCT05310994 | Completed

• 1 other identifier: CMUH111-REC3-028
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of Wasabi Leaf Extract on skin

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (12)

• 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 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 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 Outcomes (8)

• The change of skin hydration

  Change from Baseline skin hydration at 8 weeks

• The change of UV spots

  Change from Baseline UV spots at 8 weeks

• The change of brown spots

  Change from Baseline brown spots at 8 weeks

• The change of Advanced glycation end products of blood

  Change from Baseline AGEs at 8 weeks

• The change of liver function biomarkers (AST, ALT) of blood

  Change from Baseline liver function biomarkers at 8 weeks

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Wasabi Leaf Extract Drink

EXPERIMENTAL

Dietary Supplement: Wasabi Leaf Extract Drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Placebo drink

Wasabi Leaf Extract Drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Also known as: Wasabi (Wasabia japonica) leaf extract drink

Wasabi Leaf Extract Drink

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Hsiu-Mei Chiang, Prof.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

• Po-Yuan Wu, Dr.

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: March 28, 2022
• Primary Completion: June 15, 2022
• Study Completion: July 31, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

TW (1)