UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032852 |
|---|---|
| Receipt number | R000037367 |
| Scientific Title | Effect of Hand Antisepsis on Skin Protection |
| Date of disclosure of the study information | 2018/06/03 |
| Last modified on | 2018/12/04 10:50:12 |
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Basic information
Public title
Effect of Hand Antisepsis on Skin Protection
Acronym
Effect of Hand Antisepsis on Skin Protection
Scientific Title
Effect of Hand Antisepsis on Skin Protection
Scientific Title:Acronym
Effect of Hand Antisepsis on Skin Protection
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of hand antisepsis on skin protection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Indexes for skin protection (skin viscoelasticity, moisture content [before application, 5th time after application, 10th time after application)
Key secondary outcomes
[1]Feeling questionnaire (10th time after application)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of test product A (10 times).
Interventions/Control_2
Application of test product B (10 times).
Interventions/Control_3
Application of test product C (10 times).
Interventions/Control_4
Application of control product A (10 times).
Interventions/Control_5
Application of control product B (10 times).
Interventions/Control_6
Application of control product C (10 times).
Interventions/Control_7
Application of control product D (10 times).
Interventions/Control_8
Application of control product E (10 times).
Interventions/Control_9
No application (10 times).
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Males or females aged 20-64 years.
[2]Nurse and laboratory technician who works at a hospital with an Infection Control Committee and an Infection Control Nurse.
[3]Nurse and laboratory technician who uses hand antisepsis daily.
[4]Nurse and laboratory technician whose written informed consent has been obtained.
[5]Nurse and laboratory technician who can have an examination in a designated day.
[6]Nurse and laboratory technician judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals with strange skin conditions at measurement points.
[3]Individuals with a scar, an inflammation, eczema, and sunburn on measurement points (inside of the arm and palm).
[4]Individuals who are sensitive to alcohol.
[5]Individuals with probable skin disease such as itching, rubefaction, and eczema.
[6]Individuals who are or are possibly, or are lactating.
[7]Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Nakata |
Organization
Medical Corporation Bokushinkai CLINTEXE Clinic
Division name
Head
Zip code
Address
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL
+81-3-5405-1059
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoma Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
GOJO Japan, Inc.
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
Address
Tel
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
| 2018 | Year | 06 | Month | 03 | 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
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
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037367
