UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059156 |
|---|---|
| Receipt number | R000067669 |
| Scientific Title | Effects of the intake of test product on skin condition |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/22 14:07:23 |
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Basic information
Public title
Effects of the intake of test product on skin condition
Acronym
Effects of the intake of test product on skin condition
Scientific Title
Effects of the intake of test product on skin condition
Scientific Title:Acronym
Effects of the intake of test product on skin condition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the test product on the skin function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin function
Key secondary outcomes
Subjective feeling questionnaire
Oxidative stress
Gut environment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test product for 6 weeks.
Interventions/Control_2
Intake the placebo product for 6 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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | > |
Gender
Female
Key inclusion criteria
1.Healthy female adults who are aged between 18 and 24 years at the time of informed consent.
2.Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.
Key exclusion criteria
Subjects --
1.who are currently undergoing medical treatment by doctor and using medication.
2.judged by the principal investigator to be unsuitable for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakuta |
Organization
SHOWA WOMEN'S UNIVERSITY
Division name
Department of Health Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
TEL
+81-3-3411-7401
t-sakuta@swu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakuta |
Organization
SHOWA WOMEN'S UNIVERSITY
Division name
Department of Health Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
TEL
+81-3-3411-7401
Homepage URL
t-sakuta@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa Women's University institutional review board
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
Tel
+81-3-3411-7351
kenkyu@swu.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
| 2025 | Year | 10 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067669
