UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055703 |
|---|---|
| Receipt number | R000063645 |
| Scientific Title | Research on the scalp, hair, and facial skin |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2025/04/03 09:13:24 |
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Basic information
Public title
Research on the scalp, hair, and facial skin
Acronym
Research on the scalp, hair, and facial skin
Scientific Title
Research on the scalp, hair, and facial skin
Scientific Title:Acronym
Research on the scalp, hair, and facial skin
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 correlation between scalp, hair and facial skin.
Basic objectives2
Others
Basic objectives -Others
To determine the correlation between scalp, hair and facial skin.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation with the physical property of scalp/facial skin and hair type
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Key inclusion criteria
1. Japanese male aged 20-59 living in the Tokyo area.
Key exclusion criteria
1. Those who have allergic reactions to chemicals, dust, ethanol, pollen, etc. on the skin
2. Those who have skin hypersensitivity
3. Those who have surgical scars on the head
4. Those who have scars or pimples on the face more than 6.
5. Those who have skin symptoms such as atopic dermatitis, contact dermatitis, seborrheic dermatitis on the face
6. Those who have skin symptoms such as atopic dermatitis, contact dermatitis, seborrheic dermatitis, etc. on the scalp
7. Those who will be exposed to sunlight for a long period of time during the period of cooperation in the study
8. Those who have undergone chemical treatment of the hair within the past month from the time of recruitment
9. Those who are experiencing rapid hair loss or hair falling out in patches
10. Those whose hair ratio of gray hair exceeds that of black hair when not dyed
11. Those who are skinhead or short hair less than 4 cm in length
12. Those who have undergone hair transplantation or hair extension, or who use a hair wig that cannot be removed by themselves
13. Those who have used any medicines including hair regrowth agents on the scalp in the past year
14. Those who have orally ingested any drug that shows hair regrowth effect in the past 1 year
15. Those who regularly take supplements that may have an effect of reducing skin inflammation
16. Those who regularly take supplements that may improve or prevent hair loss
17. Those who have a history or current history of serious illnesses such as diabetes, liver disease, renal disease, or cardiac disease
18. Those who have received any vaccination within 2 weeks prior to the start of participation in the study
19. Those who work for a cosmetics company, etc.
20. Those who are planning to participate in other clinical trials or monitoring surveys during the study period
21. Those who is otherwise deemed inappropriate as a research subject by the person in charge of conducting the research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Yuki |
Organization
Kao Corporation
Division name
Hair Care 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 Care 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
+81-3-5630-9064
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
| 2024 | Year | 10 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular.
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063645
