UMIN-CTR Clinical Trial

Basic information
Public title	Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Acronym	Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Scientific Title	Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Scientific Title:Acronym	Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Region	Japan

Condition
Condition	Atopic dermatitis, Psoriasis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess whether results of Whole blood cytokine release assay can predict the drug effect.
Basic objectives2	Others
Basic objectives -Others	evaluation of assay system
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between suppressive ability of the drugs assessed by Whole blood cytokine release assay and clinical effect of the drugs on individual atopic dermatitis or psoriasis patient.
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	Atopic dermatitis patient, psoriasis patient who undergo at the department of dermatology at Tohoku University Hospital
Key exclusion criteria	patient who is administrated biologics.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Setsuya Middle name Last name Aiba
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
TEL	022-717-7271
Email	saiba@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Kimura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
TEL	022-717-7271
Homepage URL
Email	yutakakimura@m.tohoku.ac.jp

Sponsor
Institute	Department of Dermatology Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the Ethics Committee of Tohoku University Graduate School of Medicine
Address	1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
Tel	022-717-7145
Email	hospikken@bureau.tohoku.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	2015 Year 05 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	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Date of IRB	2013 Year 03 Month 26 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	whole blood from 6 healthy volunteer was assessed

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020150