UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062048 |
|---|---|
| Receipt number | R000070992 |
| Scientific Title | Parallel group comparison study of two hair tonics |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/24 17:42:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of hair growth efficacy applying hair tonic
Acronym
Study of hair growth efficacy
Scientific Title
Parallel group comparison study of two hair tonics
Scientific Title:Acronym
Parallel group comparison study of two hair tonics
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the hair growth efficacy of hair tonic B
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hair density of hair tonic B application
Key secondary outcomes
hair diameter, hair elongation, anagen hair ratio, terminal hair ratio, stratum corneum hydration, thickness of dermis, subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply hair tonic A twice a day for 24 weeks
Interventions/Control_2
Apply hair tonic B twice a day for 24 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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Participants who have indicated their intention to participate in the study, understand the explanations given, and have obtained informed consent.
2) Healthy Japanese females between the ages of 30 and 69 who have not violated the exclusion criteria.
3) Participants with feelings of thinning hair and hair loss.
4) Participants who can fill out consent forms, questionnaires, and use a diary.
Key exclusion criteria
1) Participants with pathological hair loss such as alopecia areata.
2) Have a scalp disorder other than alopecia (eczema, psoriasis, tinea capitis, or other scalp infections).
3) Participants with underactive or abnormal thyroid function.
4) Participants with atopic dermatitis.
5) Participants with sun sensitivity.
6) Participants who have ever experienced hypersensitivity to hair restorers, shampoos, or other external medicines.
7) Participants who have experienced hypersensitivity to rubbing alcohol, hair growth products, or other cosmetics containing alcohol.
8) Pregnant, lactating, or intending to become pregnant.
9) Received hormone replacement therapy within the past year or are taking oral contraceptives.
10) Received radiation therapy to the head or cancer chemotherapy treatment within the past 6 months.
11) Participants undergoing hair transplantation or hair extension treatment.
12) Participants who have used medicinal hair-growth agents (minoxidil, carpronium chloride, etc.) or quasi-drugs for hair growth within the past 6 months.
13) Participants who habitually apply or ingest other topical or oral medications, or dietary supplements that may affect the scalp or hair.
14) Participants with a remarkably high percentage of gray hair on the head.
15) Participants who wear hats, helmets, wigs, etc., during the examination period.
16) Participants who consume excessive amounts of alcohol.
17) Participants with a history of serious hepatic, renal, cardiac disease, circulatory system disease, or psychiatric disease.
18) Participants who have a family member who works for a pharmaceutical or cosmetics company.
19) Participants who are currently participating or have participated within the past 3 months in clinical trials, usage surveys, or product monitoring related to cosmetics and pharmaceuticals.
20) Other Participants deemed ineligible for this study by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Jindo |
Organization
Yamada Bee Company, Inc.
Division name
Apitherapy Cosmetics department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, Japan
TEL
03-6424-8434
sj1383@yamada-bee.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Takahashi |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company Group Institute for Beauty Science, R&D department
Zip code
144-0055
Address
#406 Innoba Ota., 4-32-6 Nakarokugou, Ota-ku, Tokyo, Japan
TEL
03-6424-8434
Homepage URL
rt2067@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Center
Address
2972-8-603 Ishikawamachi, Hachioji-shi, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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
| 2026 | Year | 07 | 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
| 2026 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 24 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070992
