UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040243 |
|---|---|
| Receipt number | R000045910 |
| Scientific Title | A crossover commercial "hand alcohol disinfection gel item A" commissioning test for healthy medical staffs for four weeks |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2020/04/27 10:35:27 |
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Basic information
Public title
A crossover commercial "hand alcohol disinfection gel item A" commissioning test for healthy medical staffs for four weeks
Acronym
A crossover commercial "hand alcohol disinfection gel item A" commissioning test for healthy medical staffs for four weeks
Scientific Title
A crossover commercial "hand alcohol disinfection gel item A" commissioning test for healthy medical staffs for four weeks
Scientific Title:Acronym
A crossover commercial "hand alcohol disinfection gel item A" commissioning test for healthy medical staffs for four weeks
Region
| Japan |
Condition
Condition
Healthy medical staffs who work for Hospitals of St. Marianna University School of Medicine
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the dermatological, bacteriological efficacy of commercial "hand alcohol disinfection gel A" for healthy medical staff skin around hand
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Amount of S. aureus on hands
-Degree of scaling, roughness, redness, pain, itching on hands
Key secondary outcomes
-Amount of Aerobic bacterium except S. aureus on hands
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Hand alcohol disinfection traditionally using in hospital.
>Commercial "hand alcohol disinfection A" for 4 weeks
>Hand alcohol disinfection traditionally using in hospital for 4 weeks (washout period)
>Placebo formulation B for 4 weeks (cross over period)
>Hand alcohol disinfection traditionally using in hospital
Interventions/Control_2
Hand alcohol disinfection traditionally using in hospital.
>Placebo formulation B for 4 weeks
>Hand alcohol disinfection traditionally using in hospital for 4 weeks (washout period)
>Commercial "hand alcohol disinfection A" for 4 weeks (cross over period)
>Hand alcohol disinfection traditionally using in hospital
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
Healthy medical staffs who work for Hospitals of St. Marianna University School of Medicine
Key exclusion criteria
-Subjects using steroid drug
-Subjects seeing dermatological doctor during test
-Subjects who suffer from atopic dermatitis, or contact dermatitis
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kunishima |
Organization
St. Marianna University School of Medicine
Division name
Department of infectious diseases
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa prefecture, 216-8511, JAPAN
TEL
+81-44-977-8111
h2kuni@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Asaoka |
Organization
Kao Corporation
Division name
Household lab.
Zip code
640-8580
Address
1334 Minato, Wakayama-shi, Wakayama prefecture, 640-8580, JAPAN
TEL
+81-73-426-7995
Homepage URL
asaoka.kentarou@kao.com
Sponsor or person
Institute
St. Marianna University School of Medicine
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
+81-3-5630-9220
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045910
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| Registered date | File name |
| Research case data | |
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