UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020176 |
|---|---|
| Receipt number | 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 10:21:01 |
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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
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
ebitamo@z6.keio.jp
Sponsor or person
Institute
Department of Dermatology
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023308
