UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004284
Receipt number R000005038
Scientific Title Searching for the optimal cyclosporin A treatment method for atopic dermatitis
Date of disclosure of the study information 2010/09/28
Last modified on 2018/12/31 09:14:00

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Basic information

Public title

Searching for the optimal cyclosporin A treatment method for atopic dermatitis

Acronym

Treatment with cyclosporin A for atopic dermatitis

Scientific Title

Searching for the optimal cyclosporin A treatment method for atopic dermatitis

Scientific Title:Acronym

Treatment with cyclosporin A for atopic dermatitis

Region

Japan


Condition

Condition

atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recently, usage of cyclosporin A to atopic dermatitis covered by insurance. However, its administration method has not been established. The aim of this study is to establish the safety and efficacy of cyclosporin A against atopic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) severity of atopic dermatitis with scoring by Rajka&Langeland.
2) serum TARC level
3) used amount of ointment.
4) ratio and duration of disease flare-up.
5) QOL with DLQI, itch VAS, and sleep disturbance VAS.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

cessation of drug after 3 months (no dose reduction)

Interventions/Control_2

cessation of drug after 3 months (dose reduction)

Interventions/Control_3

continuous dosing (no dose reduction)

Interventions/Control_4

continuous dosing (dose reduction)

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) diagnosis of severe atopic dermatitis
2) intractable case with atopic dermatitis (resistant with ordinary dose of steroid ointment application)
3)over 16 years old
4) acceptable economic matters for patients
5) patients are no contraindication to cyclosporin A.
6) Regardless of gender

Key exclusion criteria

1) patients are contraindication to cyclosporin A
2) patients are required careful administration of cyclosporin A
3) Patients during the PUVA therapy
4) excluding at aphysician's direction

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HIROYUKI MUROTA

Organization

Osaka university

Division name

Dept. of dermatology

Zip code


Address

2-2, Yamadaoka, Suita, Osaka

TEL

0668795111

Email

h-murota@derma.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name 0668795111

Organization

Osaka univeristy

Division name

Dermatology

Zip code


Address

2-2, Suita

TEL

0668795111

Homepage URL


Email

h-murota@derma.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka univeristy

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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

2010 Year 09 Month 28 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

2010 Year 02 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 28 Day

Last modified on

2018 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name