UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031417 |
|---|---|
| Receipt number | 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 14:30:15 |
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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
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
enya-kazunori@ichimaru.co.jp
Sponsor or person
Institute
SOUKEN Co.,Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
