UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060316 |
|---|---|
| Receipt number | R000068992 |
| Scientific Title | Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis: a single-arm before-and-after study |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/10 12:12:28 |
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Basic information
Public title
Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis: a single-arm before-and-after study
Acronym
Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis
Scientific Title
Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis: a single-arm before-and-after study
Scientific Title:Acronym
Evaluation of changes in quality of life with the use of functional innerwear in patients with atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in patient-reported quality of life associated with the use of functional innerwear in patients with atopic dermatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLQI (Dermatology Life Quality Index), Skindex16
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
This study is a single-arm before-and-after study designed to evaluate changes in quality of life and symptoms associated with the use of T-shirts made from a functional fiber (BP) developed by Spiber Inc. in patients with atopic dermatitis (AD). After completing baseline assessments (Visits 1 and 2), participants will undergo post-intervention assessments during a T-shirt wearing period of six weeks (Visits 3, 4, and 5). The maximum intervention period will be eight weeks, during which participants will wear the T-shirts according to a three-phase schedule. Each T-shirt will be worn continuously for 24 hours per day, except during bathing, and participants will be instructed to wear the T-shirt at all times during both daytime and nighttime. To standardize laundering conditions, a designated fragrance-free, low-irritant detergent will be provided, and participants will be instructed to wash the T-shirts at home using only the provided detergent and to avoid the use of fabric softeners or bleaching agents. These measures are intended to minimize the influence of differences in laundering conditions and to ensure a fair evaluation of the textile material itself.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older at the time of obtaining informed consent.
Patients diagnosed with atopic dermatitis.
Patients with mild to moderate disease severity at the time of enrollment (Eczema Area and Severity Index (EASI) under 21).
Key exclusion criteria
1) Patients with serious comorbid conditions, such as severe cardiac, hepatic, renal, pulmonary, or hematologic diseases, that are considered inappropriate for participation in this clinical study.
2) Patients with a current or prior history of malignant neoplasms. However, patients with a history of malignancy who are not receiving active treatment and have remained recurrence-free for at least five years at the time of obtaining informed consent will be eligible for inclusion.
3) Patients who have participated in another post-marketing clinical study within 120 days prior to enrollment (defined as the date of the last administration of an investigational or study drug), or who are currently participating in another clinical study or post-marketing clinical trial.
4) Patients who are otherwise deemed ineligible for participation in this clinical study by the principal investigator or study investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | AYANO |
| Middle name | |
| Last name | NOMURA |
Organization
Keio University
Division name
Department of Dermatology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
0333531211
ayano-fukushima@keio.jp
Public contact
Name of contact person
| 1st name | AYANO |
| Middle name | |
| Last name | NOMURA |
Organization
Keio University
Division name
Department of dermatology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
0333531211
Homepage URL
ayano-fukushima@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Spiber Inc.
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
0333531211
med-nintei-jimu@adst.keio.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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | 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
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068992
