UMIN-CTR Clinical Trial

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
Email	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
Email	t_numa_925@yahoo.co.jp

Sponsor
Institute	Department of Dermatology,Hiroshima University, Hiroshima, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026941