UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059202 |
|---|---|
| Receipt number | R000067713 |
| Scientific Title | Research on hair root responsiveness and hair growth effects |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/26 14:42:47 |
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Basic information
Public title
Research on hair root responsiveness and hair growth effects
Acronym
Research on hair root responsiveness and hair growth effects
Scientific Title
Research on hair root responsiveness and hair growth effects
Scientific Title:Acronym
Research on hair root responsiveness and hair growth effects
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 relationship between the responsiveness of hair follicles and hair growth effects.
Basic objectives2
Others
Basic objectives -Others
To determine the relationship between the responsiveness of hair follicles and hair growth efficacy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relation with the rate of hair diameter changes and hair root genes before and after 16 weeks of use of test products.
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
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply hair growth product to the right side of the head twice a day for 16wks.
Interventions/Control_2
Apply hair growth product to the left side of the head twice a day for 16wks.
Interventions/Control_3
Apply placebo to the right side of the head twice a day for 16wks.
Interventions/Control_4
Apply placebo to the left side of the head twice a day for 16wks.
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.
2. Those whose hair condition corresponds to II vertex, II, IIa, III vertex, III, IIIa, IV, or IVa according to the Hamilton-Norwood classification.
3. Those who are not using anti hair loss products at the time of recruitment into the study, or who agree to discontinue using them from the time of receiving an explanation of the study.
Key exclusion criteria
1. Those who have allergic reactions to ethanol on the skin.
2. Those who have surgical scars on the head.
3. Those who have skin symptoms such as atopic dermatitis, contact dermatitis, seborrheic dermatitis, etc. on the scalp.
4. Those who have undergone chemical treatment of the hair within the past one month from the time of recruitment.
5. Those who are experiencing acute hair loss or hair falling out in patches.
6. Those whose gray hair ratio exceeds that of black hair when not dyed.
7. Those who are skinhead or short hair less than 4 cm in length.
8. Those who have undergone hair transplantation or hair extension.
9. Those who have used any medicines including hair regrowth agents on the scalp in the past one month.
10. Those who have orally ingested any drug that shows hair regrowth effect in the past one month.
11. Those who regularly take supplements that may have an effect of reducing skin inflammation.
12. Those who regularly take supplements that may improve or prevent hair loss.
13. Those who have a history or current history of serious illnesses such as diabetes, liver disease, renal disease, or cardiac disease.
14. Those who have received any vaccination within 2 weeks prior to the start of participation in the study.
15. Those who are planning to participate in other clinical trials or monitoring surveys during the study period.
16. Those who is otherwise deemed inappropriate as a research subject by the person in charge of conducting the research.
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 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
| 2025 | Year | 09 | Month | 26 | 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 | 09 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067713
