UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039758 |
|---|---|
| Receipt number | 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 09:19:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
