UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000031423