UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063232 |
|---|---|
| Receipt number | R000072373 |
| Scientific Title | An Exploratory Comparative Study of Scalp and Hair Changes Following Continuous Shampoo Use |
| Date of disclosure of the study information | 2026/10/28 |
| Last modified on | 2026/10/09 15:30:21 |
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Basic information
Public title
An Exploratory Comparative Study of Scalp and Hair Changes Following Continuous Shampoo Use
Acronym
An Exploratory Comparative Study of Scalp and Hair Changes Following Continuous Shampoo Use
Scientific Title
An Exploratory Comparative Study of Scalp and Hair Changes Following Continuous Shampoo Use
Scientific Title:Acronym
An Exploratory Comparative Study of Scalp and Hair Changes Following Continuous Shampoo Use
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of continuous use of two different shampoos on the scalp and hair.
Basic objectives2
Others
Basic objectives -Others
To compare and investigate how continuous use of two different shampoos affects the scalp and hair.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent change in scalp TEWL from baseline (Week 0) to Week 4
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Use the test shampoo to wash the entire scalp and hair at least once daily for 4 weeks.
Interventions/Control_2
Use the control shampoo to wash the entire scalp and hair at least once daily for 4 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Women aged 20-59 years.
2. Women who wash their hair with shampoo at least 6 times per week.
Key exclusion criteria
1. Persons who develop skin redness following exposure to ethanol.
2. Persons with abnormal skin conditions at the study site, such as atopic dermatitis or seborrheic dermatitis.
3. Persons who have undergone chemical hair treatments (e.g., hair coloring, bleaching, or perming) within 2 weeks prior to the start of the study period.
4. Persons who are already participating in another study at the time of informed consent or who plan to participate in another study during the study period.
5. Persons deemed unsuitable for participation in the study by the principal investigator due to noncompliance with study requirements or for other reasons.
Target sample size
24
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 | Tamaki |
| Middle name | |
| Last name | Hirano |
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
hirano.tamaki@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
+81-70-3300-8553
watanabe.takuya@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 | 10 | Month | 28 | 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 | 10 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | 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 | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072373
