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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005059
Receipt No. 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

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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
Email 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
Email ykiniwa@shinshu-u.ac.jp

Sponsor
Institute Department of dermatology, Nihon university Itabashi hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006013

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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