UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049316 |
|---|---|
| Receipt number | R000056163 |
| Scientific Title | Evaluation of hair growth of test product A |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2023/03/23 16:51:38 |
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Basic information
Public title
Evaluation of hair growth of test product A
Acronym
Test NC
Scientific Title
Evaluation of hair growth of test product A
Scientific Title:Acronym
Test NC
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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
test product
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male Pattern Baldness in Japan
Key exclusion criteria
A person who has participated in an examination of an investigational drug or medical device within the past six months.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Tubota |
Organization
Nicca Chemical co.,Ltd.
Division name
Cosmetics Research Dept. DEMI Cosmetics
Zip code
910-8670
Address
Fukuisi bunkyo
TEL
0776-25-8582
miki-tsubota@demicosmetics.com
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Fujii |
Organization
Nicca Chemical co.,Ltd.
Division name
Cosmetics Research Dept. DEMI Cosmetics
Zip code
910-8670
Address
Fukuisi bunkyo
TEL
0776-25-8582
Homepage URL
y-fujii@demicosmetics.com
Sponsor or person
Institute
Nicca Chemical 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
SOUKEN Co.,Ltd.
Address
1-9-10, Minato-ku Hamamatu-chou, Tokyo Japan
Tel
03-5408-1555
m_katou@mail.souken-r.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
| 2022 | Year | 10 | Month | 25 | 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
22
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
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | 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=R000056163
