UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054642 |
|---|---|
| Receipt number | R000062441 |
| Scientific Title | Study of hair growth effect by liposomalized NMN-added berry extract |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/06/12 15:23:09 |
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Basic information
Public title
Investigation of hair regrowth and hair growth effect by NMN
Acronym
Examination of hair regrowth and hair growth effects
Scientific Title
Study of hair growth effect by liposomalized NMN-added berry extract
Scientific Title:Acronym
Study of hair growth effect by liposomal NMN
Region
| Japan |
Condition
Condition
thinning hair
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation of hair growth and hair regrowth promoting effect of liposomalized NMN-added berry extract coating
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The increase in head hair volume during the first 70 days of application is evaluated by quantifying the images taken.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Two mL of liposomalized NMN-added berry extract will be sprayed once daily for approximately ten weeks. Six application tests will be performed: just before the application test, on the 14th day, on the 28th day, on the 42nd day, on the 56th day, and on the 70th day after the start of the application. Photographs taken will be analyzed using software to evaluate their effectiveness.
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
1. Healthy male and female volunteers
2. Between 20 and 70 years of age
3. Be able to provide written informed consent
Key exclusion criteria
With a critical disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Imai |
Organization
ByU-Analytica Inc.
Division name
Division of Research and Development
Zip code
565-0871
Address
2-1 Yamadaoka, Suita, Osaka
TEL
06-6879-4177
imai@byuanalytica.com
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Imai |
Organization
ByU-Analytica Inc.
Division name
Division of Research and Development
Zip code
565-0871
Address
2-1 Yamadaoka, Suita, Osaka
TEL
06-6879-4177
Homepage URL
imai@byuanalytica.com
Sponsor or person
Institute
ByU-Analytica 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
ByU-Analytica Ethics Review Board
Address
1-8-3 Nakanoshima, Kita-ku, Osaka-shi, Osaka
Tel
06-7777-1415
rinri@byuanalytica.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 | 12 | 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
20
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 | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062441
