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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039758
Receipt No. R000045347
Scientific Title Study on antibacterial effect and smell of armpit reduction effect of erythritol application
Date of disclosure of the study information 2020/03/11
Last modified on 2020/09/08

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Basic information
Public title Study on antibacterial effect and smell of armpit reduction effect of erythritol application
Acronym Deodorant test of erythritol application
Scientific Title Study on antibacterial effect and smell of armpit reduction effect of erythritol application
Scientific Title:Acronym Deodorant test of erythritol application
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate antibacterial effect and smell of armpit reduction effect after 24 hours by applying the test product
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intensity of smell of armpit by sensory evaluation after 24 hours the test product application
Key secondary outcomes Type of smell of armpit by sensory evaluation after 24 hours the test product application
Smell of armpit related bacteria count
Physical examination (height, weight, BMI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Prevention
Type of intervention
Other
Interventions/Control_1 After washing the body, apply erythritol-containing solution to the same subject's right armpit.
Interventions/Control_2 After washing the body, apply an erythritol-free solution (placebo) to the same subject's left armpit.
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
16 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 16 years old or more and under 60 years old
3. Persons who are concerned about smell of armpit
4. Select 20 patients taking into account the intensity of smell of armpit, gender and age at the screening
Key exclusion criteria 1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who have a smoking habit
3. Persons who have a hospital visit for treatment of smell of armpit
4. Persons who regularly drink a large amount (more than 3 Japanese sake per day)
5. BMI less than 18.5, 25 or more
6. Persons who are on a diet
7. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
8. Persons with menopausal symptoms (subjective symptoms such as hot flashes), immediately after menopause
9. Workers on the night shift
10. Persons who regularly use medicines, specified insurance foods, and health foods that may affect smell of armpit
11. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
12. Persons who are judged as inappropriate for subjects by the principal investigator
13. Persons who have remarkably different intensity of smell of armpit between left and right armpit at the screening
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email masudat@hc-sys.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email masudat@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization B Food Science Co., Ltd. and others
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 The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email kakehashi@hc-sys.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 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 18
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
2020 Year 03 Month 04 Day
Date of IRB
2020 Year 03 Month 04 Day
Anticipated trial start date
2020 Year 03 Month 14 Day
Last follow-up date
2020 Year 03 Month 21 Day
Date of closure to data entry
2020 Year 04 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 10 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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