UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054408 |
|---|---|
| Receipt number | R000060565 |
| Scientific Title | Study of the effect of hand sanitizers on changes in physical condition during winter |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2025/05/19 08:44:12 |
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Basic information
Public title
Efficacy test of the hand sanitizer
Acronym
Efficacy test of the hand sanitizer
Scientific Title
Study of the effect of hand sanitizers on changes in physical condition during winter
Scientific Title:Acronym
Efficacy test of the hand sanitizer
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the hand sanitizer on changes in physical condition during the winter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of symptoms associated with changes in physical condition after 10 weeks of use of hand sanitizers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply hand sanitizer to hands at least 5 less than 10 times a day for 10 wks.
Interventions/Control_2
Apply control to hands at least 5 less than 10 times a day for 10 wks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy man and woman aged 20-65
2. Person who employees of Kao corporation and its group companies and their family members living with them.
Key exclusion criteria
1. Person who has undergone medication or surgery due to serious illness or injury within 2 months of the start of this study.
2. Person who taking steroids.
3. Person who has symptoms of roughness or itchy hands, such as hand eczema or dermatitis.
4. Person who has a low tolerance for alcohol and cannot use hand alcohol sanitizers.
5. Person who cannot agree to restrictions on the use of the test product and the specified hand cream only.
6. Person who shift worker.
7. Parson who join other human studies related to changes in physical condition
8. Parson who deemed inappropriate by the principal investigator due to non-compliance or other reasons.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hayase |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7231
hayase.atsuko@kao.com
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Yamanaka |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
yamanaka.nami2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2024 | Year | 05 | Month | 16 | 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
578
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060565
