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
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
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
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
