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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004284
Receipt No. 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

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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
Institute Osaka univeristy
Institute
Department

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
URL(English) https://upload.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


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