UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043438 |
|---|---|
| Receipt number | R000049563 |
| Scientific Title | Analysis of microbiota in a normal resident of the skin in atopic dermatitis and compared with non-atopic dermatitis |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2023/09/11 18:09:14 |
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Basic information
Public title
The study of difference of skin microbiota in atopic dermatitis and in non-atopic dermatitis
Acronym
The study of skin microbiota in atopic dermatitis
Scientific Title
Analysis of microbiota in a normal resident of the skin in atopic dermatitis and compared with non-atopic dermatitis
Scientific Title:Acronym
Analysis of microbiota in a normal resident of the skin in atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of microbiota in a normal resident of the skin, and investigate transepidermal water loss and water content in atopic dermatitis compared with non-atopic dermatitis .
Basic objectives2
Others
Basic objectives -Others
Observation characteristics of physiological function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of microbiota in a normal resident of the skin
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Twenty years over atopic dermatitis patients who go to or go into Osaka Medical College Hospital, and twenty years over non-atopic dermatitis volunteers.
Key exclusion criteria
Under twenty years old people.
Twenty years over atopic dermatitis patients and non-atopic dermatitis volunteers, difficult to judge on themselves
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Moriwaki |
Organization
Osaka Medical College Hospital
Division name
Department of Dermatology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki,Osaka
TEL
072-683-1221
der002@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Adachi |
Organization
Osaka Medical College Hospital
Division name
Department of Dermatology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki,Osaka
TEL
072-683-1221
Homepage URL
der075@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Projects to support the advancement of strategic core technologies
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics commottee in Osaka Medical College Hospital
Address
2-7 Daigakumachi, Takatsuki,Osaka
Tel
072-683-1221
rinri@art.osaka-med.ac.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
| 2021 | Year | 03 | Month | 05 | 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
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe case-control sample, there is a difference of skin microbiota because of the skin barrier function or not.
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049563
