UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023390 |
|---|---|
| Receipt number | R000026941 |
| Scientific Title | Double-blind randomized parallel intergroup trial about the efficacy of the immobilized antibacterial ingredient Etak processing shirt for atopic dermatitis |
| Date of disclosure of the study information | 2016/07/29 |
| Last modified on | 2022/02/01 13:29:25 |
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Basic information
Public title
Double-blind randomized parallel intergroup trial about the efficacy of the immobilized antibacterial ingredient Etak processing shirt for atopic dermatitis
Acronym
Double-blind randomized parallel intergroup trial about the efficacy of the immobilized antibacterial ingredient Etak processing shirt for atopic dermatitis
Scientific Title
Double-blind randomized parallel intergroup trial about the efficacy of the immobilized antibacterial ingredient Etak processing shirt for atopic dermatitis
Scientific Title:Acronym
Double-blind randomized parallel intergroup trial about the efficacy of the immobilized antibacterial ingredient Etak processing shirt for atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is that we test the advantage of the improvement effect on placebo shirt of the Etak processing shirt (change> of score <physique part [shirt wearing site] objective SCORAD by the diagnosis of the atopic symptom by the physician) of atopic dermatitis by the multicenter randomized parallel intergroup trial for the patients 70 years or younger 16 years old that a symptom of atopic dermatitis is stable in its or older for the purpose of this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SCORAD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
the immobilized antibacterial ingredient Etak processing shirt
Interventions/Control_2
Shirt roughness
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age at agreement acquisition is the patient 70 years or younger 16 years old or older
The patients with atopic dermatitis (the patients that a rank of the steroid medicine for external application prescribed for one month does not have a change) who are stable in their symptom for one month
The patients that there is not serious underlying disease such as the serious heart disorder, and the overall status is stable
The patients that an agreement is obtained in a document from the person about participation of this study
Key exclusion criteria
The patients who receive steroid internal use therapy, cyclosporine internal use therapy
The patients in the physique part without a symptom of atopic dermatitis
The patients whom the shirt is not their size
The patients who admitted that it was inadequate so that a study person in charge or a study partaker underwent this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takahagi |
Organization
Hiroshima University, Hiroshima, Japan
Division name
Department of Dermatology,
Zip code
734-8551
Address
1-2-3 Kasumi, minamiku ,Hiroshima ,Hiroshima University, Hiroshima, Japan
TEL
082-257-5238
shunstk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Numata |
Organization
Hiroshima University, Hiroshima, Japan
Division name
Department of Dermatology,
Zip code
734-8551
Address
1-2-3 Kasumi, minamiku ,Hiroshima ,Hiroshima University, Hiroshima, Japan
TEL
082-257-5238
Homepage URL
t_numa_925@yahoo.co.jp
Sponsor or person
Institute
Department of Dermatology,Hiroshima University, Hiroshima, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Oral Biology & Engineering
Integrated Health Sciences
Institute of Biomedical and Health Sciences
Hiroshima University
Department of Dermatology,Hiroshima University, Hiroshima, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, minamiku ,Hiroshima ,Hiroshima University, Hiroshima, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
| 2016 | Year | 07 | Month | 29 | 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
| 2016 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026941
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
