UMIN-CTR Clinical Trial

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