UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005059 |
|---|---|
| Receipt number | R000006013 |
| Scientific Title | Efficacy of proactive therapy by topical corticosteroids for atopic dermatitis |
| Date of disclosure of the study information | 2011/02/09 |
| Last modified on | 2015/08/10 17:49:53 |
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Basic information
Public title
Efficacy of proactive therapy by topical corticosteroids for atopic dermatitis
Acronym
proactive therapy for atopic dermatitis
Scientific Title
Efficacy of proactive therapy by topical corticosteroids for atopic dermatitis
Scientific Title:Acronym
proactive therapy for atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Atopic dermatitis is a chronic condition that is variable in severity and age onset. For good maintenance of atopic dermatitis, topical steroids following daily emollients and intermittent corticosteroids may be effective than topical steroids following emollients alone. To provide evidence for this speculation, we evaluate efficacy of proactive therapy by topical corticosteroids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SCORAD
IGA
DLQI
itchy VAS
side effects of topical steroids
frequency of medication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Four weeks topical betamethasone butyrate propionate following daily emolients and betamethasone butyrate propionate at twice a week
Interventions/Control_2
Four weeks topical betamethasone butyrate propionate following daily emolients
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
consented adult patients with intermediate severity of atopic dermatitis with
Key exclusion criteria
hypersensitivity of betamethasone butyrate propionate and/or emollients
disability of judgement
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuhei Okuyama |
Organization
Shinshu university school of medicine
Division name
Department of dermatology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2647
ykiniwa@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Kiniwa |
Organization
Shinshu university school of medicine
Division name
Department of dermatology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2647
Homepage URL
ykiniwa@shinshu-u.ac.jp
Sponsor or person
Institute
Department of dermatology, Nihon university Itabashi hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of dermatology, Tohoku university school of medicine
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 09 | 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
| 2011 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 09 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006013
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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