UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044792 |
|---|---|
| Receipt number | R000051157 |
| Scientific Title | Evaluation of hair growth effects by application of hair lotion containing lactic-acid bacteria |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2023/07/07 09:46:00 |
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Basic information
Public title
Evaluation of hair growth effects by application of hair lotion containing lactic-acid bacteria
Acronym
Evaluation of hair growth effects by application of hair lotion containing lactic-acid bacteria
Scientific Title
Evaluation of hair growth effects by application of hair lotion containing lactic-acid bacteria
Scientific Title:Acronym
Evaluation of hair growth effects by application of hair lotion containing lactic-acid bacteria
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate hair growth effects by application of hair lotion containing lactic-acid bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phototrichogram (number of hairs at anagen and telogen, number of hairs, hair diameter, ratio of softened hairs and non-softened hairs, hair growth coefficient)
at 0-12-24w
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply lactic acid bacteria-containing lotion for 24 weeks
Interventions/Control_2
Apply the placebo lotion for 24 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to 59 years old at the time of informed consent
2) Subjects who are aware of their thinning hair
3) Subjects who can consent to have their hair partially cut by a hairdresser
4) Subjects who can consent not to change their hair conditioning method (hair length, hair style, perm, etc.), hair dyeing method and hair washing method
Key exclusion criteria
1) Subjects who can be allergic to ingredients of the test product
2) Subjects who are taking/applying medicines for hair growth that can affect the test result
3) Subjects who are taking supplements for hair growth that can affect the test result
4) Subjects who have sensitive skin or possibility of allergy to the test product
5) Subjects who currently go to the dermatology
6) Pregnant or breastfeeder. Those who desire pregnancy and lactation
7) Subjects who participate in other clinical trials
8) Subjects who are using shampoo/conditioner for hair growth
9) Subjects with underlying medical conditions such as diabetes, chronic respiratory disease, chronic heart disease, hypertension, chronic kidney disease, chronic liver disease, chronic blood disease, neurological disease, neuromuscular disease, chromosomal abnormalities and severe psychosomatic disorders
10) Subjects who are taking medical treatments
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 08 | Month | 20 | 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
110
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 | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051157
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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