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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042252
Receipt No. R000048245
Scientific Title Evaluating the impact of wearing TRI-KNIT shirt on atopic dermatitis: a pilot study
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/27

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Basic information
Public title Evaluating the impact of wearing TRI-KNIT shirt on atopic dermatitis: a pilot study
Acronym The impact of wearing TRI-KNIT shirt on atopic dermatitis:
Scientific Title Evaluating the impact of wearing TRI-KNIT shirt on atopic dermatitis: a pilot study
Scientific Title:Acronym Evaluating the impact of wearing TRI-KNIT shirt on atopic dermatitis: a pilot study
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to explore the effects of atopic dermatitis on the skin and dermatitis status of patients with atopic dermatitis during the wearing of TRI-KNIT shirts. The results of this exploratory study can be expected to bring important suggestions for lifestyle guidance aimed at long-term maintenance of atopic dermatitis remission. It is an exploratory study to confirm the changes in the results of various tests and subjective assessments before and after the period of wearing this shirt.
Basic objectives2 Others
Basic objectives -Others The impact on symptoms will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual analogue scale (VAS) for itch
EASI: The Eczema Area and Severity Index
Key secondary outcomes Patient background: gender, age, medical history, and treatment
Laboratory tests: white blood cell count, serum TARC (which is covered by insurance as a measure of the severity of atopic dermatitis), and IgE level
POEM (patient oriented eczema measure): a self-administered assessment of the severity of the disease, a seven-question questionnaire
TSQM9 (treatment satisfaction questionnaire for medication-9): A questionnaire with nine questions to assess satisfaction with the TRI-KNIT.
Assessment of skin flora: swab the middle of the upper dorsal area
Skin pH: measured by placing the probe of the measuring instrument on the skin. Non-invasive.
Exfoliated moisture content: measured by placing the probe of the instrument on the skin. Non-invasive.
Skin Moisture Checker: A patch that can be evaluated by simply applying it to the skin to check skin moisture content, which is sold by Life Care Giken. It is non-invasive. It is applied to the middle of the upper back, which is usually covered by clothing, for 5 minutes before and after the examination to evaluate the skin moistness.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 TRI-KNIT shirts
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 1 Age 20 years or older 2 Gender Any gender 3 For outpatients. 4 Patients who have received sufficient information and understanding of the study, and who have given their free written consent to participate in the study. 5 Patients who have not shown any improvement in their symptoms after the same treatment in the last two months (this is the definition of refractory for this study).
Key exclusion criteria none
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Morisaki
Organization Nagasaki university
Division name Dermatology
Zip code 8528501
Address 1-7-1, Sakamoto, Nagasaki city
TEL 095-819-7333
Email h-morisaki@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Morisaki
Organization Nagasaki university
Division name Dermatology
Zip code 8528501
Address 1-7-1, Sakamoto, Nagasaki city
TEL 095-819-7333
Homepage URL
Email h-morisaki@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki univrsity
Institute
Department

Funding Source
Organization ITOCHU Textile Prominent(ASIA)Limited
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 Clinical research cencer, Nagasaki univrtsity
Address 1-7-1 Sakamoto
Tel 095-819-7726
Email rinshou7726@umin.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
2020 Year 11 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 27 Day
Last modified on
2020 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048245

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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