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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027423
Receipt No. R000031423
Scientific Title Qualitative and quantitative changes in skin T cells during treatments of skin disorders
Date of disclosure of the study information 2017/06/01
Last modified on 2019/05/23

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Basic information
Public title Qualitative and quantitative changes in skin T cells during treatments of skin disorders
Acronym Skin disorders and skin T cells
Scientific Title Qualitative and quantitative changes in skin T cells during treatments of skin disorders
Scientific Title:Acronym Skin disorders and skin T cells
Region
Japan

Condition
Condition inflammatory skin disorders, allergic skin disorders, collagen disease
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the qualitative and quantitative changes in skin T cells and blood T cells during treatments of skin disorders and to find the specific changes of skin T cells according to treatment modalities.
Basic objectives2 Others
Basic objectives -Others To reveal the changes of skin T cells before and after treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentages of CCR7+CD62L+ central memory T cells, CCR7+CD62L- migratory memory T cells and CD69+CD103+ resident memory T cells in total T cells in lesional skin, non-lesional skin and blood before and after treatments.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 To collect skin biopsy specimens and blood samples after skin lesion is cleared by any kinds of treatments
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 The skin disorder patients whose skin lesions disappeared after any kinds of treatments and who underwent skin biopsies for the sake of diagnosis before treatments.
Key exclusion criteria None
Target sample size 45

Research contact person
Last name of lead principal investigator
1st name Manabu
Middle name
Last name Fujimoto
Organization University of Tsukuba
Division name Division of Medicine, Department of Dermatology
Zip code 305-8575
Address 1-1-1, Tennodai, Tsukuba-shi, Ibaraki, Japan
TEL 029-853-3128
Email rwatanabe@md.tsukuba.ac.jp

Public contact
1st name of contact person
1st name Rei
Middle name
Last name Watanabe
Organization University of Tsukuba
Division name Division of Medicine, Department of Dermatology
Zip code 305-8575
Address 1-1-1, Tennodai, Tsukuba-shi, Ibaraki, Japan
TEL 029-853-3128
Homepage URL
Email rwatanabe@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Medicine, University of Tsukuba
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
Tel +81298533128
Email rwatanabe@md.tsukuba.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
2017 Year 06 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
2007 Year 04 Month 18 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 21 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031423

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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