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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031417
Receipt No. R000035620
Scientific Title Validation of improvement of several symptoms and alteration of facial flora by application of cream
Date of disclosure of the study information 2019/10/01
Last modified on 2018/02/22

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Basic information
Public title Validation of improvement of several symptoms and alteration of facial flora by application of cream
Acronym Validation of alteration of facial flora by application of cream
Scientific Title Validation of improvement of several symptoms and alteration of facial flora by application of cream
Scientific Title:Acronym Validation of alteration of facial flora by application of cream
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We performe controlled before-and-after trial in order to validate improvement of several symptoms and alteration of facial flora by application of cream
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of transepidermal water loss
Measurement of epidermal water content
Submission of analyte
Measurement of melanin index and erythema
Measurement of skin color
Questionnate study
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Application of cream
Interventions/Control_2
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
60 years-old >=
Gender Female
Key inclusion criteria 1. Japanese women from 20 to 60 years old
2. People who mind their rough skin
3. People who mind their color and dullness on skin
4. People who mind makeup deterioration
5. People who can use test sample instead of their own cleansing form and cream.
6. People who can use only their own moisturizing lotion and test cream without any other cream, gel or facial mask during the test period.
Key exclusion criteria 1. Pregnant women, women of childbearing potential or lactating women
2. People who are allergic to cosmetics
3. People who had be treated cosmetic or medical treatment that possibly effect on test region
4. People who are involved to other clinical investigation
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazue Takayama
Organization Ichimaru Pharcos Co., Ltd.
Division name Product Development
Zip code
Address 318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL 058-320-1036
Email takayama-kazue@ichimaru.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Enya
Organization Ichimaru Pharcos Co., Ltd.
Division name Product Development
Zip code
Address 318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL 058-320-1037
Homepage URL
Email enya-kazunori@ichimaru.co.jp

Sponsor
Institute SOUKEN Co.,Ltd
Institute
Department

Funding Source
Organization Ichimaru Pharcos Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 10 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 20 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 02 Month 22 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035620

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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