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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041127
Receipt No. 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 2020/07/16

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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
Email 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
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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