UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062753 |
|---|---|
| Receipt number | R000071844 |
| Scientific Title | Exploratory Study of Changes in Skin Function Following Intake of Ume Extract Umulin |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 17:49:55 |
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Basic information
Public title
Exploratory Study of Changes in Skin Function Following Intake of Ume Extract Umulin
Acronym
Umulin Skin Study
Scientific Title
Exploratory Study of Changes in Skin Function Following Intake of Ume Extract Umulin
Scientific Title:Acronym
Umulin Skin Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratively assess changes in subjective indicators of skin condition in healthy adults following 8 weeks of oral intake of ume extract and to obtain basic data for future confirmatory studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline to 8 weeks in subjective skin condition scores assessed by questionnaire.
Key secondary outcomes
Changes from baseline to 8 weeks in the following parameters:
Transepidermal water loss (TEWL) measured using Tewameter TM300
Stratum corneum hydration measured using Skicon-200EX
Spots, wrinkles, skin brightness, and redness assessed using re-Beau2
Skin elasticity measured using Cutometer MPA580
Dermal structure or collagen-related parameters assessed using the DermaLab skin analysis system
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of 7.2 g of ume extract (Umulin) concentrate once daily for approximately 8 weeks.
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women aged 25 to 60 years who are judged by the principal investigator to have no apparent skin disease.
2.Individuals who have received sufficient explanation regarding the purpose, methods, study period, and questionnaire procedures of the study, understand the contents, and provide written informed consent of their own free will.
3.Employees, trainees, or students affiliated with Wakayama Medical University who do not meet any of the exclusion criteria.
Key exclusion criteria
1.Individuals undergoing treatment for severe skin disease.
2.Individuals considered unable to participate continuously throughout the study period.
3.Individuals concurrently participating in another skin-related clinical study.
4.Individuals with a history of hypersensitivity or allergy to Umulin.
5.Employees of Kishu Hosokawa Co., Ltd.
6.Staff members of the Department of Dermatology, Wakayama Medical University.
7.Staff members, trainees, or students involved in dermatological clinical practice or research at Wakayama Medical University.
8.Individuals involved in the conduct, evaluation, analysis, or decision regarding publication of the results of this study.
9.Individuals judged by the investigator to be unsuitable for participation in the study for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Department of Dermatology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan
TEL
073-447-2300
yukiy@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hirata |
Organization
Wakayama Medical University
Division name
Department of Dermatology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan
TEL
073-447-2300
Homepage URL
kazuki-hope@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Kishu Hosokawa Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-441-0896
wa-rinri@wakayama-med.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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | 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
There is currently no plan to share anonymized individual participant data with third parties. Any future secondary use of data will be conducted only after appropriate ethical review and institutional approval.
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 17 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071844
