UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041127 |
|---|---|
| Receipt number | R000046940 |
| Scientific Title | Verification and Comparison of Skin Care Lotion and Its Feeling. |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2021/06/25 09:38:30 |
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Basic information
Public title
Verification and Comparison of Skin Care Lotion and Its Feeling.
Acronym
Verification and Comparison of Skin Care Lotion and Its Feeling.
Scientific Title
Verification and Comparison of Skin Care Lotion and Its Feeling.
Scientific Title:Acronym
Verification and Comparison of Skin Care Lotion and Its Feeling.
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 verify and compare of skin care lotion and its feeling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Feeling questionnaire (single use; applying four test products separately).
Key secondary outcomes
[1]Doctor's questions (before and after applying the test product).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of test product A (1 time).
> Application of test product B (1 time).
> Application of test product C (1 time).
> Application of test product D (1 time).
Interventions/Control_2
Application of test product B (1 time).
> Application of test product C (1 time).
> Application of test product D (1 time).
> Application of test product A (1 time).
Interventions/Control_3
Application of test product C (1 time).
> Application of test product D (1 time).
> Application of test product A (1 time).
> Application of test product B (1 time).
Interventions/Control_4
Application of test product D (1 time).
> Application of test product A (1 time).
> Application of test product B (1 time).
> Application of test product C (1 time).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Females aged 30-49 years.
[2]Nurse and laboratory technician who use a hand sanitizer and wear gloves at daily work.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can have an examination in a designated day.
[5]Individuals 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.
[4]Individuals who are sensitive to alcohol.
[5]Individuals who are or are possibly, or are lactating.
[6]Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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 | 07 | Month | 17 | 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
| 2020 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 19 | 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 | 07 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046940
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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