UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026052 |
|---|---|
| Receipt number | R000029305 |
| Scientific Title | Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/10/23 18:32:17 |
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Basic information
Public title
Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Acronym
Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Scientific Title
Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Scientific Title:Acronym
Clinical study of mixed formulation with corticosteroid and moisturizer for asteatotic eczema
Region
| Japan |
Condition
Condition
asteatotic eczema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparative testing of Steroid ointment and steroid ointment+moisturizer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
disease severity after application for 2weeks.
Key secondary outcomes
itching score, skin surface hydration, sweating, texture of skin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
steroid ointment and steroid containing moisturizer
Interventions/Control_2
7days and 14 days
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
Older than 20yo.
agree to participate in this trial.
person with asteatotic eczema distributed symmetrically.
Key exclusion criteria
Person with allergic dermatitis other than asteatotic eczema.
Person with bacterial skin infection.
Sever atopic dermatitis patient.
Person who has hypersensitivity for steroid or steroid containing moisturizer
Person who enrolled in other clinical trial within a month.
Person who was disqualified by principal clinician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Department of dermatology, Kawasaki Medical School
Division name
Dermatology
Zip code
701-0192
Address
086-462-1111
TEL
086-462-1111
ymaoyama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Department of dermatology, Kawasaki Medical School, 577 Matsushima Kurashiki city, Okayama Japan
Division name
Dermatology
Zip code
701-0192
Address
086-462-1111
TEL
086-462-1111
Homepage URL
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of dermatology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima Kurashiki Japan
Tel
086-462-1111
kmsrec@med.kawasaki-m.ac.jp
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
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 22 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029305
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
