UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032330
Receipt number R000036869
Scientific Title Analysis of immunological abnormalitiy in inflammatory skin diseases
Date of disclosure of the study information 2018/05/01
Last modified on 2021/04/23 11:06:59

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Basic information

Public title

Analysis of immunological abnormalitiy in inflammatory skin diseases

Acronym

Analysis of immunological abnormalitiy in inflammatory skin diseases

Scientific Title

Analysis of immunological abnormalitiy in inflammatory skin diseases

Scientific Title:Acronym

Analysis of immunological abnormalitiy in inflammatory skin diseases

Region

Japan


Condition

Condition

atopic dermatitis, psoriasis, Behcet's disease

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the immunological abnormality of inflammatory cells in inflammatory skin diseases

Basic objectives2

Others

Basic objectives -Others

To investigate the mechanism of protein regulation in inflammatory cells in inflammatory skin diseases

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the abnormality of cytokine production and signal transduction pathways induced by inflammatory cells

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

Other

Interventions/Control_1

To take blood samples from patients

Interventions/Control_2

To take blood samples from healthy controls

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

18 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with atopic dermatitis, psoriasis, Behcet disease, and other inflammatory skin diseases. healthy controls (over 18 year old, under 70 year old).

Key exclusion criteria

persons which is not involed in the category above.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Koichiro
Middle name
Last name Nakamura

Organization

Saitama Medical University

Division name

Department of Dermatology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi,Irumagun, Saitama

TEL

049-276-1247

Email

nakamu@saitama-med.ac.jp


Public contact

Name of contact person

1st name Koichiro
Middle name
Last name Nakamura

Organization

Saitama Medical University

Division name

Department of Dermatology

Zip code

350-0495

Address

38 Morohongo, Moroyama-machi,Irumagun, Saitama

TEL

049-276-1247

Homepage URL


Email

nakamu@saitama-med.ac.jp


Sponsor or person

Institute

Department of Dermatology, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

General Research Field of Dermatology

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

Saitama Meddical University

Address

38 Morohongo, Moroyama-machi, Iruma-gun

Tel

0492762143

Email

nakamu@saitama-med.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

2018 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

28

Results

Peripheral blood were collected and dendritic cells were generated . Cytokine production was measured.

Results date posted

2021 Year 04 Month 23 Day

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

2014 Year 04 Month 25 Day

Date of IRB

2014 Year 04 Month 25 Day

Anticipated trial start date

2014 Year 04 Month 25 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 04 Month 20 Day

Last modified on

2021 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036869


Research Plan
Registered date File name
2021/04/23 Microsoft.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name