UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044574 |
|---|---|
| Receipt number | R000050917 |
| Scientific Title | Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2022/03/25 13:26:46 |
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Basic information
Public title
Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use
Acronym
RHG01
Scientific Title
Efficacy Confirmation Test of Hair Growth and Nurturing Composition (HGT) in Continuous Use
Scientific Title:Acronym
RHG01
Region
| Japan |
Condition
Condition
thinning hair
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract) for women with thinning hair.
To study the effectiveness of the hair growth agent HGT (containing carrot extract, soy protein hydrolysate, and seaweed extract)
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
Single blind -investigator(s) and assessor(s) 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
Use hair growth products (active) 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 (placebo) 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
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Japanese between the ages of 40 and 70 years old
(2) Women with thinning hair equivalent to Ludwig Scale I-2 to II-2 as of the date of consent.
(3) The purpose and content of the study will be explained to the research subjects prior to the study, and the research subjects themselves are capable of making decisions and have given their written consent.
Key exclusion criteria
(1) Those who have hair transplants or wear wigs.
(2) Those who may show allergic symptoms to the components of the test substance.
(3) Those who may show allergic symptoms to the test substance or those who have skin hypersensitivity.
Those who have a history of serious heart disease, renal disease, liver disease, cancer, or 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) Women who are pregnant or may become pregnant, and women who are breastfeeding.
(7) Others whom the principal investigator deems inappropriate to be included in the study.
Target sample size
68
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
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO 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
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
医療法人社団TMC 東京メモリアルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 12 | 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
67
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 | 06 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050917
