UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056783 |
|---|---|
| Receipt number | R000064905 |
| Scientific Title | Test on the effect of applying test products on reducing armpit odor |
| Date of disclosure of the study information | 2025/01/22 |
| Last modified on | 2025/07/23 09:07:39 |
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Basic information
Public title
Test on the effect of applying test products on reducing armpit odor
Acronym
Test on the effect of applying test products on reducing armpit odor
Scientific Title
Test on the effect of applying test products on reducing armpit odor
Scientific Title:Acronym
Test on the effect of applying test products on reducing armpit odor
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of applying a cream containing miconazole nitrate to the armpits of Japanese adult men and women aged 18 to 65 years on reducing effect of armpit odor after 24 hours.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Armpit odor intensity evaluation (sensory evaluation, 6-level scale, left and right)
Key secondary outcomes
Evaluation of armpit odor types (sensory evaluation, 7 types, 6 levels, left and right)
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
The cream containing miconazole nitrate and the placebo product were applied to the right and left armpits, respectively, and subjects were asked to live as usual for 24 hours, while avoiding bathing and the use of deodorant products.
Interventions/Control_2
The cream containing miconazole nitrate and the placebo product were applied to the left and right armpits, respectively, and subjects were asked to live as usual for 24 hours, while avoiding bathing and the use of deodorant products.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | 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.Japanese adult men and women between the ages of 18 and 65.
3.Persons who have been noted to have a strong armpit odor and are aware of it.
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 are allergic to the test food
4.Persons taking warfarin
5.Persons who have a hospital visit for treatment of smell of armpit
6.Persons who regularly drink a large amount (more than 3 Japanese sake per day)
7.Persons who are on a diet
8.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
9.Persons with menopausal symptoms (subjective symptoms such as hot flashes), immediately after menopause
10.Workers on the night shift
11.Persons who regularly use medicines, specified insurance foods, and health foods that may affect smell of armpit
12.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
13.Persons who were judged as inappropriate for study participants by the principal investigator
14.Persons whose armpit odor intensity differs significantly between the left and right sides at screening
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, 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
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, 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
Mochida Healthcare 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
03-6809-2722
soumu@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
| 2025 | Year | 01 | Month | 22 | 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
36
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
| 2025 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2025 | Year | 01 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064905
