UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045441 |
|---|---|
| Receipt number | R000051845 |
| Scientific Title | Evaluation of hair growth of test product A |
| Date of disclosure of the study information | 2021/09/14 |
| Last modified on | 2023/03/23 16:50:25 |
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Basic information
Public title
Evaluation of hair growth of test product A
Acronym
Test A
Scientific Title
Evaluation of hair growth of test product A
Scientific Title:Acronym
Test A
Region
| Japan |
Condition
Condition
androgenetic alopecia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
androgenetic alopecia improvement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breeding hair function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
placebo
Interventions/Control_2
test product
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Male Pattern Baldness in Japan
Key exclusion criteria
People who have wigs, extensions, hair transplants, or hair extensions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Matsushima |
Organization
Kobayashi Pharmaceutical Co.,Ltd.
Division name
New product and business development dept
Zip code
567-0057
Address
1-30-3, Toyokawa,Ibaraki-city,Osaka
TEL
08096605332
yu.matsushima@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Naganuma |
Organization
DRC CO.,Ltd.
Division name
Product testing Department
Zip code
530-0044
Address
No9 Tabuchi Building 3F 2-10-31, Higashi tenma, Kita-ku, Osaka
TEL
0668821130
Homepage URL
naganuma@drc-web.co.jp
Sponsor or person
Institute
DRC CO.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi pharmaceutical Co.,Ltd.
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
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, Tokyo
Tel
03-6273-2214
ethics_board@drc-web.co.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
| 2021 | Year | 09 | Month | 14 | 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
66
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051845
