UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Acronym	Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Scientific Title	Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Scientific Title:Acronym	Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Region	Japan

Condition
Condition	Vitiligo vulgaris
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	This study aims to clarify the pathogenesis of vitiligo vulgaris and regulatory mechanism of HLA-A expression using molecular biology techniques.
Basic objectives2	Others
Basic objectives -Others	This study aims to clarify the pathogenesis of vitiligo vulgaris and regulatory mechanism of HLA-A expression using molecular biology techniques.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Measurement of HLA-A mRNA and the activity of HLA-A regularoty region using peripheral blood of Japanese volunteers.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Gene
Interventions/Control_1	The peripheral blood is taken from Japanese volunteers. Genomic DNA is extracted from blood and significant SNPs for vitiligo risk are genotyped. The volunteers are classified into two groups, and subsequently their HLA-A mRNA is measured. This group is high risk.
Interventions/Control_2	This group is non-high risk.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	No specific condition is needed.
Key exclusion criteria	No specific exclusion is needed.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Hayashi
Organization	Yamagata University School of Medicine
Division name	Department of Dermatology
Zip code	9909585
Address	2-2-2 Iida-Nishi, Yamagata
TEL	023-628-5361
Email	czk11223@nifty.ne.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Hayashi
Organization	Yamagata University School of Medicine
Division name	Department of Dermatology
Zip code	9909585
Address	2-2-2 Iida-Nishi, Yamagata
TEL	023-628-5361
Homepage URL
Email	czk11223@nifty.ne.jp

Sponsor
Institute	Yamagata University School of Medicine, Department of Dermatology
Institute
Department

Funding Source
Organization	Ministry of education and science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	the Ethical Review Committee of Yamagata University Faculty of Medicine
Address	2-2-2 Iida-Nishi, Yamagata
Tel	023-628-5047
Email	ikekenkyu@jm.kj.yamagata-u.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	山形大学医学部

Other administrative information
Date of disclosure of the study information	2016 Year 04 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	Delay expected
Results Delay Reason	The time to analyze the data was longer than we initially anticipated.
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	2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	None.

Management information
Registered date	2016 Year 02 Month 14 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024220