UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052684 |
|---|---|
| Receipt number | R000059955 |
| Scientific Title | Study of the Effects on Hair Growth in Women with Thinning Hair on Continuous Use of TMD1 Hair Growth Products |
| Date of disclosure of the study information | 2023/11/05 |
| Last modified on | 2024/11/01 11:12:46 |
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Basic information
Public title
Study of the Effects on Hair Growth in Women with Thinning Hair on Continuous Use of TMD1 Hair Growth Products
Acronym
Study of the Effects on Hair Growth in Women with Thinning Hair on Continuous Use of TMD1 Hair Growth Products
Scientific Title
Study of the Effects on Hair Growth in Women with Thinning Hair on Continuous Use of TMD1 Hair Growth Products
Scientific Title:Acronym
Study of the Effects on Hair Growth in Women with Thinning Hair on Continuous Use of TMD1 Hair Growth Products
Region
| Japan |
Condition
Condition
Hair thinning
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether TMD1 affects hair growth in women with thinning hair using phototrichograms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in number of hairs after 24 weeks of use
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Placebo TMD1 hair growth product applied to the scalp twice daily for 24 weeks
Interventions/Control_2
Apply a middle concentration of TMD1 hair growth product to the scalp twice daily for 24 weeks
Interventions/Control_3
Apply a high concentration of TMD1 hair growth product to the scalp twice daily for 24 weeks
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Asian women between the ages of 45 and 65
2. Subjects with thinning hair equivalent to Ludwig Scale I-2 to II-2
3. Subjects who have been informed of the purpose and content of the study prior to the study, have the capacity to make decisions, and have given their written consent.
Key exclusion criteria
1. Those who have undergone hair transplantation
2. Persons who have dyed, bleached or permanent hair within 3 months of the screening test.
3. Persons who may show allergic symptoms to test substance components.
4. Persons who may show skin allergy symptoms or skin hypersensitivity.
5. Persons with a history of serious heart disease, renal disease, liver disease, cancer, or thyroid dysfunction in the past.
6. Persons who have not used health foods, cosmetics, quasi-drugs, or medicines that may affect the test results for more than 6 months.
7. Women who are pregnant or possibly pregnant and women who are breast-feeding
8. Other persons whom the principal investigator deems inappropriate to be included in the study.
Target sample size
51
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
Formation Surgery
Zip code
151-0053
Address
2-16-7 Yoyogi, 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
Re-Life.inc
Division name
Clinical Development Division
Zip code
170-0005
Address
3-37-2 Minami-Otsuka, Toshima-ku, Tokyo
TEL
03-5985-0077
Homepage URL
hkatsuta@relife-inc.com
Sponsor or person
Institute
TMC Medical Corporation,Tokyo Memorial Clinic
Institute
Department
Personal name
Funding Source
Organization
EADERM Corporation
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
Ethics Review Committee, Abe Clinic, San-yukai Medical Corporation
Address
6-60-10 Higashinippori, Arakawa-ku, Tokyo
Tel
03-5958-7017
abecl-rinri@medicos-group.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
| 2023 | Year | 11 | Month | 05 | 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
51
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
| 2023 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059955
