UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054607 |
|---|---|
| Receipt number | R000062334 |
| Scientific Title | Study to evaluate hair growth effect by test food intake. |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2024/12/16 10:37:28 |
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Basic information
Public title
Hair growth trial
Acronym
Hair growth trial
Scientific Title
Study to evaluate hair growth effect by test food intake.
Scientific Title:Acronym
Study to evaluate hair growth efficacy.
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the hair growth effect of the test food on at least 20 adult male subjects suffering from thinning hair after 24 weeks of continuous intake of the test food by comparing before and after intake of the test food by the same subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Photo Trichogram (Hair diameter, Hair growth rate, Anagen hair percentage)
Key secondary outcomes
General clinical examinations, Questionnaire survey, Head photography (top of head), Adverse event investigation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take test food for 12 weeks+2 days.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Subjects who are worried about thinning hair and hair loss.
(2)Subjects with type II vertex to type III vertex or type II to type III in the Hamilton-Norwood classification (mainly type II vertex to type III vertex).
(3)Subjects who can obtain written consent at their own discretion before the study begins.
Key exclusion criteria
(1)Persons with inflammation or skin disease at the evaluation site (scalp).
(2)Persons with factors that may affect the results of the test at the evaluation site (disease such as hives,inflammation,eczema,external wound,acne,pustules,warts,pigmented spots,etc.,or traces thereof).
(3)Persons with a past medical history or current medical history of atopic dermatitis or persons with a predisposition to atopic dermatitis.
(4)Persons who have received, or plan to receive during the study period, medical cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photo facials, etc.) to the evaluation site.
(5)Persons who have undergone or will undergo within the past 4 weeks or during the study period any special skin care treatment (beauty salon, beauty treatment, head spa, etc.) for the evaluation site.
(6)Persons are continuously using skin care products, cosmetics, quasi-drugs or health foods, topical products (pharmaceuticals and quasi-drugs), and oral medications (pharmaceuticals) with efficacy claims (hair growth efficacy) similar to or related to the efficacy studied in this study for the evaluation site.
(7)Persons who have used health foods and basic skin care cosmetics, health foods and supplements (saw palmetto, zinc, etc.) used in the evaluation site or shampoos/conditioners/treatments that claim to be effective for hair growth, hair loss, or hair loss within the past 4 weeks.
(8)Persons using cosmetics (hair tonic, etc.) on the evaluated site.
(9)Persons who have been exposed to ultraviolet radiation beyond daily activities such as prolonged outdoor work, exercise, swimming, leisure activities, etc., within the past 4 weeks or plan to do so during the study period.
(10)Persons working night shifts and day/night shifts.
And others (omitted due to overcapacity).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuhma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC CO., LTD.
Division name
Efficacy Testing of Cosmetics and Foods Group
Zip code
530-0044
Address
No9 Tabuchi Building 3F 2-10-31, Higashi tenma, Kita-ku, Osaka, Japan
TEL
06-6882-1130
yoshida@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Michita |
| Middle name | |
| Last name | Hayashi |
Organization
NIKODERM RESEARCH INC.
Division name
Sales Department
Zip code
541-0052
Address
1-6-14 Azuchimachi, Chuo-ku, Osaka City, OSAKA, JAPAN
TEL
06-6125-3501
Homepage URL
mhayashi@nikkolgroup.com
Sponsor or person
Institute
Oryza Oil&Fat Chemical.,Ltd.
Institute
Department
Personal name
Hiroshi Shimoda
Funding Source
Organization
Oryza Oil&Fat Chemical.,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
Brain Care Clinic Ethics Review Committee.
Address
Shiratori Build 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.co.jp
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
DRC株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 11 | 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
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
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 12 | 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 | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062334
