UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061239 |
|---|---|
| Receipt number | R000070074 |
| Scientific Title | A Study to Evaluate the Moisturizing and Skin Barrier Effects of the Shampoo and Conditioner |
| Date of disclosure of the study information | 2026/04/17 |
| Last modified on | 2026/04/13 08:48:47 |
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Basic information
Public title
A Study to Evaluate the Moisturizing and Skin Barrier Effects of the Shampoo and Conditioner
Acronym
A Study to Evaluate the Moisturizing and Skin Barrier Effects of the Shampoo and Conditioner
Scientific Title
A Study to Evaluate the Moisturizing and Skin Barrier Effects of the Shampoo and Conditioner
Scientific Title:Acronym
A Study to Evaluate the Moisturizing and Skin Barrier Effects of the Shampoo and Conditioner
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the moisturizing and skin barrier effects of the shampoo or conditioner by measuring stratum corneum hydration and transepidermal water loss before and after application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change ratio in transepidermal water loss at the application site on the inner forearm from before application to after
application of the test products
Key secondary outcomes
Change ratio in water content at the application site on the inner forearm from before application to after application of the test products
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Two types of shampoo and two types of conditioner will each be applied once.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Male and Female aged 20-59
Key exclusion criteria
1. Persons with severe diseases affecting the heart, lungs, kidneys, liver, blood, endocrine system, skin, or any other organ or system.
2. Persons with atopic dermatitis, contact dermatitis, or other skin disorders, or with wounds or scars, at the application sites on the inner forearms.
3. Persons with a history of allergic reactions, such as dermatitis related to cosmetics.
4. Persons who plan to expose the application sites on the inner forearms to substantial direct sunlight from two weeks before the study day until the end of the study, such as daytime sports on consecutive days.
5. Persons who plan to participate in other clinical trials or monitoring surveys from two weeks before the study day until the end of the study.
6. Persons deemed unsuitable for participation by the investigator for any other reason.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Yuki |
Organization
Kao Corporation
Division name
Hair Beauty Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81--3-5630-9395
yuki.katsuyuki@kao.com
Public contact
Name of contact person
| 1st name | Yuuki |
| Middle name | |
| Last name | Ina |
Organization
Kao Corporation
Division name
Hair Beauty Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9395
Homepage URL
ina.yuuki@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 04 | Month | 17 | 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 | 04 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 05 | 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 | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070074
