UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061432 |
|---|---|
| Receipt number | R000070104 |
| Scientific Title | Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 13:58:46 |
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Basic information
Public title
Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol
Acronym
Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol
Scientific Title
Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol
Scientific Title:Acronym
Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical Study on the Efficacy of a Cream Containing gamma-Oryzanol in Healthy Women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in sebum levels of the skin after application
Key secondary outcomes
Changes in transepidermal water loss (TEWL), skin hydration, skin viscoelasticity, melanin level, and erythema score after of application
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will apply a cream containing rice bran-derived gamma-oryzanol to one side of the face twice daily (morning and evening) for 8 consecutive weeks. Assessments will be conducted on the cheek and forehead areas.
Interventions/Control_2
Participants will apply a placebo cream to one side of the face twice daily (morning and evening) for 8 consecutive weeks. Assessments will be conducted on the cheek and forehead areas.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Women between the ages of 30 and 60 at the time consent is obtained.
2. Healthy and free from chronic physical diseases, confirmed by medical interview.
3. The applicant must not be using any medicated cosmetics, supplements, or other products that are expected to have related efficacy.
4. Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding the details, and can provide written consent to participate in this trial.
5. Individuals who can attend the designated examination date and undergo the examination.
6. Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
1. Who currently suffer from any disease and are under medication.
2. Who have been determined by the examining physician to have a serious skin condition such as dermatitis.
3. Who cannot intentionally refrain from being exposed to direct sunlight, such as sunburn, during the examination period.
4. Who show statistical outliers in measurements of primary and secondary endpoints.
5. Who have allergies (to pharmaceuticals or products related to the test materials).
6. Who is pregnant, lactating, or intends to become pregnant during the study period.
7. Who are currently, or have been within the past month at the time of consent, in the habit of continuously ingesting or applying a drug that relation to the area to be measured.
8. Who are otherwise deemed by the investigator to be inappropriate for the study.
Target sample size
25
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
Planning and Development Dept. 3, Research and Development Div.
Zip code
649-7194
Address
2283 Chonomachi, Katsuragi-cho, Ito-gun, Wakayama, 649-7194, Japan
TEL
0736-26-5032
nakamura.toshio@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
Section 1, Planning and Development Dept. 3, Research and Development Div.
Zip code
649-7194
Address
2283 Chonomachi, Katsuragi-cho, Ito-gun, Wakayama, 649-7194, Japan
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
Funding Source
Organization
Tsuno Rice Fine Chemicals Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakayama Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsuno Food Industrial Ethics Committee
Address
94 Shinden, Katsuragi-cho, Ito-gun, Wakayama, 649-7194, Japan
Tel
0736-22-0061
rd_3dept@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
築野ライスファインケミカルズ株式会社 TIWセンター（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070104
