UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2020 Year 10 Month 27 Day
Date of IRB	2020 Year 10 Month 31 Day
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	2021 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 09 Month 30 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 27 Day
Last modified on	2022 Year 10 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048245