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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020176
Receipt No. R000023308
Scientific Title The efficacy of the topical steroid lotion for atopic dermatitis
Date of disclosure of the study information 2015/12/13
Last modified on 2018/07/19

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Basic information
Public title The efficacy of the topical steroid lotion for atopic dermatitis
Acronym The efficacy of the topical steroid lotion for atopic dermatitis
Scientific Title The efficacy of the topical steroid lotion for atopic dermatitis
Scientific Title:Acronym The efficacy of the topical steroid lotion for atopic dermatitis
Region
Japan

Condition
Condition Atopic dermatits
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of switching from the topical steroid ointments to steroid lotions in atopic dermatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skin condition, clinical data
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Patients participating in this study, it is treated with topical steroid ointments of very strong class, patient
SCORAD 150 or more of adult atopic patients
Key exclusion criteria Patients with a history of hypersensitivity to
Antedate R and a moisturizer
Patients with pregnant or potentially pregnant
Patients are considered to be appropriate without
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku,Tokyo
TEL 03-5363-3823
Email ebitamo@z6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku,Tokyo
TEL 03-5363-3823
Homepage URL
Email ebitamo@z6.keio.jp

Sponsor
Institute Department of Dermatology
Keio University School of Medicine
Institute
Department

Funding Source
Organization Torii Pharmaceutical
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 07 Month 19 Day

Other
Other related information cohort study
Patient Inclusion criteria
Patients participating in this study, they visit Department of Dermatology, Keio University hospital
(2015/12/13- 2018/3/31)

Management information
Registered date
2015 Year 12 Month 12 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023308

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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