UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063515 |
|---|---|
| Receipt number | R000072695 |
| Scientific Title | A Preliminary Intervention Study Evaluating the Moisturizing Effects and Feasibility of a Hand Cream Containing Sake Lees Powder Derived from Himeiku 83 |
| Date of disclosure of the study information | 2026/11/04 |
| Last modified on | 2026/11/04 19:10:53 |
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Basic information
Public title
A Preliminary Intervention Study Evaluating the Moisturizing Effects and Feasibility of a Hand Cream Containing Sake Lees Powder Derived from Himeiku 83
Acronym
An Intervention Study on the Moisturizing Efficacy and Feasibility of a Hand Cream Containing Sake Lees Powder
Scientific Title
A Preliminary Intervention Study Evaluating the Moisturizing Effects and Feasibility of a Hand Cream Containing Sake Lees Powder Derived from Himeiku 83
Scientific Title:Acronym
A Preliminary Intervention Study on the Moisturizing Efficacy and Feasibility of a Hand Cream Containing Sake Lees Powder
Region
| Japan |
Condition
Condition
Skin condition and skin hydration
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility of using a hand cream containing sake lees powder derived from Himeiku 83 in preparation for future studies examining its moisturizing effects. Specifically, this study will assess whether the product can be used safely, whether it is suitable for medium- to long-term use, and whether it provides the basic moisturizing effects expected of a hand cream. The findings of this study are expected to provide fundamental data for the utilization of regional resources in Ehime Prefecture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
- Short-Term Study
Stratum corneum hydration
Skin moisture level
Self-reported skin problems
- Long-Term Study
Quality of life (BeautyQol)
Subjective assessment of skin condition using a visual analog scale (VAS)
Self-reported skin problems
Key secondary outcomes
- Short-Term Study
Subjective assessment of skin condition using a visual analog scale (VAS)
-Long-Term Study
Skin moisture level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
This study is an open-label, within-participant comparison study in which one hand of each participant is assigned to the intervention and the other hand to the control. The intervention and control hands are randomly assigned using a random number table.
- Short-Term Study
Approximately 0.25 g (0.5 fingertip unit, FTU) of the hand cream containing sake lees powder will be applied to the dorsum of one hand, while approximately 0.25 g (0.5 FTU) of the control hand cream without sake lees powder was applied to the dorsum of the other hand.
- Long-Term Study
Approximately 0.25 g (0.5 fingertip unit, FTU) of the hand cream containing sake lees powder will be applied to the dorsum of one hand four times daily: in the morning (06:00-09:00), at midday (11:00-14:00), in the evening (16:00-19:00),and before bedtime (21:00-24:00). No hand cream or other intervention was applied to the other hand.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ten healthy participants aged 18 to 74 years who are able to attend Ehime University (Tarumi campus), will be enrolled. High school students will be excluded.
Key exclusion criteria
1. Individuals with current skin diseases affecting the hands or arms.
2. Individuals with allergies to rice, sake lees, or any cosmetic ingredients.
3. Individuals receiving regular medical care who did not obtain permission from their
attending physician to participate in the study.
4. Individuals deemed inappropriate for participation by the principal investigator or study
physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
maruyama.kotatsu.rt@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 04 | 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 | 09 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072695
