UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058687 |
|---|---|
| Receipt number | R000064200 |
| Scientific Title | Half-face application test with ferulic acid-containing cosmetics |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/12/03 23:18:19 |
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Basic information
Public title
Half-face application test with ferulic acid-containing cosmetics
Acronym
Half-face application test with ferulic acid-containing cosmetics
Scientific Title
Half-face application test with ferulic acid-containing cosmetics
Scientific Title:Acronym
Half-face application test with ferulic acid-containing cosmetics
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of a beauty cream containing ferulic acid on the skin of healthy women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melanin level
Key secondary outcomes
spot score
stratum corneum water content
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subjects will apply ferulic acid formula to the entire face, then rinse off the product thoroughly and apply a cream, once a day for 12 weeks.
Interventions/Control_2
Subjects will apply ferulic acid formula to the entire face, then rinse off the product thoroughly and apply a cream, once a day for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Men between the ages of 20 and 60 years old.
Who can be confirmed good health and free from chrocic physical disease by medical interview.
Who not be using any cosmetics with medicinal effects.
Who have been fully informed of the purpose and content of the study, have the ability to consent, and be able to voluntarily agree to participate in the study in writing upon full understanding of the study.
Who be able to come to the laboratory on the designated examination date and be able to undergo the examination.
Who be approved participate in the study by investigator.
Key exclusion criteria
sunlight during the study period, for example, by sunbathing.
-Who show statistical outliers in measurements related to the primary and secondary outcomes of the study.
Who with allergies (to pharmaceuticals or products related to test materials).
-Who have a current or past habit of continuous ingestion or application of drugs claiming to improve the skin.
-Who use cosmetics that have a strong effect on the skin (the investigator will determine)
-Who are deemed inappropriate for this study by the investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Nakamura |
Organization
Tsuno Rice Fine Chemicals Co., LTD
Division name
Research and Development
Zip code
649-7194
Address
2283, Chonomachi, katsuragi-cho, Ito-gun, Wakayama
TEL
0736-26-5032
zhou.jingxiu@tsuno.co.jp
Public contact
Name of contact person
| 1st name | Jingxiu |
| Middle name | |
| Last name | Zhou |
Organization
Tsuno Rice Fine Chemicals Co., LTD
Division name
Research and Development
Zip code
649-7194
Address
2283, Chonomachi, katsuragi-cho, Ito-gun, Wakayama
TEL
0736-26-5032
Homepage URL
zhou.jingxiu@tsuno.co.jp
Sponsor or person
Institute
Tsuno Rice Fine Chemicals Co., LTD
Institute
Department
Personal name
Toshio Nakamura
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsuno Rice Fine Chemicals Co., LTD
Address
2283, Chonomachi, Ito-gun, Katsuragi-cho, Wakayama
Tel
0736-26-50032
Nakamura.toshio@tsuno.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
築野食品工業株式会社 TIWセンター３F 恒温恒湿室
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Twenty-four healthy adult women applied a cream containing 1% ferulic acid and a placebo to half-face for 12 weeks and were evaluated every 4 weeks.
The ferulic acid group showed a significant decrease in melanin index at 8 weeks, and a questionnaire survey at 12 weeks showed significant improvement brownish dullness, moisture, dark dullness, yellowish dullness, skin dullness, and skin translucency.
Results date posted
| 2025 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064200
