UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042252 |
|---|---|
| Receipt number | 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 | 2022/10/30 07:03:23 |
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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
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
h-morisaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki univrsity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048245
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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