UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020496 |
|---|---|
| Receipt number | R000023630 |
| Scientific Title | Analysis on an effect of long-term use of cosmetics on human skin microbiota |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2016/12/13 15:07:03 |
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Basic information
Public title
Analysis on an effect of long-term use of cosmetics on human skin microbiota
Acronym
Analysis on an effect of long-term use of cosmetics on human skin microbiota
Scientific Title
Analysis on an effect of long-term use of cosmetics on human skin microbiota
Scientific Title:Acronym
Analysis on an effect of long-term use of cosmetics on human skin microbiota
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze an effect of long-time use of cosmetics on healthy adult skin microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensively analyze microbiota for two months at several time points.
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
| Other |
Interventions/Control_1
Intervention group1
cosmetic lotion adequate amount
apply on both cheek and right cubital fossa
twice per day, 8weeks every day
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
| 22 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Male 22 years old to 39 years old
Key exclusion criteria
1. Subject who has dermatosis at target skin region
2. Subject who has allergy against cosmetic lotion which will be used for this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minory Yamahara |
Organization
Momotani Juntenkan LTD
Division name
R&D department
Zip code
Address
2-4-30 Ichioka, Minato-ku, Osaka city, Osaka
TEL
06-6571-6622
m-yamahara@e-cosmetics.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiki Tsutsui |
Organization
Momotani Juntenkan LTD
Division name
R&D department
Zip code
Address
2-4-30 Ichioka, Minato-ku, Osaka city, Osaka
TEL
06-6571-6622
Homepage URL
ttsutsui@e-cosmetics.co.jp
Sponsor or person
Institute
Momotani Juntenkan LTD
Institute
Department
Personal name
Funding Source
Organization
Momotani Juntenkan LTD
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
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
| 2016 | Year | 01 | Month | 12 | 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
| 2016 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023630
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
