UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045852 |
|---|---|
| Receipt number | R000052344 |
| Scientific Title | Efficacy verification test for continuous use of hair growth agent (AH2C) |
| Date of disclosure of the study information | 2021/11/14 |
| Last modified on | 2023/02/03 12:55:49 |
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Basic information
Public title
Efficacy verification test for continuous use of hair growth agent (AH2C)
Acronym
ACJ-01
Scientific Title
Efficacy verification test for continuous use of hair growth agent (AH2C)
Scientific Title:Acronym
ACJ-01
Region
| Japan |
Condition
Condition
thinning hair
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of hair growth agent (AH2C) on men with thinning hair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in hair diameter after 24 weeks of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Use hair growth products (Sample-P) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
Interventions/Control_2
Use hair growth products (Sample-Q) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
Interventions/Control_3
Use hair growth products (Sample-S) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
Interventions/Control_4
Use hair growth products (Sample-T) twice daily for up to 24 weeks. Phototrichograms will be performed prior to dosing, after 12 weeks of dosing, and after 24 weeks of dosing.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Japanese males between 30 and 60 years of age
(2) Patients with thinning hair equivalent to Hamilton-Norwood classification II-IV (including Type A and Vertex) as of the date of consent.
(3) Subjects who have been explained the purpose and content of the research prior to the research, and who have the capacity to make decisions and have given written consent from the research subject.
Key exclusion criteria
(1) Persons who have hair transplantation or wear wigs
(2) Persons who may show allergic symptoms to the components of the test substance
(3) Those who may show allergic symptoms to skin or those who have skin hypersensitivity
Those who have a history of serious heart disease, renal disease, liver disease, or cancer, or those who have thyroid dysfunction.
5) Those who have not used health foods, cosmetics, quasi-drugs, or medicines (e.g., hair-growth products) that may affect the test results for more than 6 months.
(6) Others whom the principal investigator judges to be inappropriate for inclusion in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Sato |
Organization
TMC Medical Corporation Tokyo Memorial Clinic
Division name
board chairman
Zip code
151-0053
Address
16-7, Yoyogi 2-chome, Shibuya-ku, Tokyo
TEL
03-5351-0309
drsato@crux.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiromu |
| Middle name | |
| Last name | Katsuta |
Organization
ReLife-inc
Division name
Clinical Development Division
Zip code
170-0013
Address
5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5928-2501
Homepage URL
hkatsuta@relife-inc.com
Sponsor or person
Institute
ADJUVANT COSME JAPAN
Institute
Department
Personal name
Funding Source
Organization
ADJUVANT COSME JAPAN
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
ReLife-inc
Address
5F Koshin Building, 1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
Tel
03-5928-2501
hkatsuta@relife-inc.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
| 2021 | Year | 11 | 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
60
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 | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052344
