UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Acronym	Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Scientific Title	Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Scientific Title:Acronym	Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Region	Japan

Condition
Condition	inflammatory skin diseases
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of miRNA expression and its function in inflammatory skin diseases
Basic objectives2	Others
Basic objectives -Others	Analysis of miRNA expression and its function in inflammatory skin diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of miRNA in serum and skin samples of patients
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with inflammatory skin diseases
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Higashi
Organization	Kagoshima University Hospital
Division name	Dermatology
Zip code	890-8520
Address	Sakuragaoka 8-35-1, Kagoshima
TEL	099-275-5850
Email	higashiy@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Higashi
Organization	Kagoshima University Hospital
Division name	Dermatology
Zip code	890-8520
Address	Sakuragaoka 8-35-1, Kagoshima
TEL	099-275-5850
Homepage URL
Email	higashiy@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Kagoshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kagoshima University Hospital
Address	8-35-1 Sakuragaoka, Kagoshima
Tel	099-275-6692
Email	crmc@m2.kufm.kagoshima-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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	12
Results	We found that several microRNAs were elevated in inflammatory skin diseases.
Results date posted	2021 Year 12 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not applicable
Participant flow	Not applicable
Adverse events	Not applicable
Outcome measures	Measurement of miRNA in serum and skin samples of patients
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 26 Day
Date of IRB	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 08 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 12 Month 28 Day
Last modified on	2021 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053062