UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060854 |
|---|---|
| Receipt number | R000069612 |
| Scientific Title | Heat-generating undergarment Effects on Atopic dermatitis: Time-stratified Web-based Individual Symptom Evaluation |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 19:11:00 |
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Basic information
Public title
Heat-generating undergarment Effects on Atopic dermatitis: Time-stratified Web-based Individual Symptom Evaluation
Acronym
HEAT-WISE Study
Scientific Title
Heat-generating undergarment Effects on Atopic dermatitis: Time-stratified Web-based Individual Symptom Evaluation
Scientific Title:Acronym
HEAT-WISE Study
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether wearing heat-generating undergarments is associated with worsening of itch in patients with atopic dermatitis using a time-stratified case-crossover design.
Basic objectives2
Others
Basic objectives -Others
Observational
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Odds ratio (95% confidence interval) for association between wearing heat-generating undergarments and worsening of itch, comparing the index day (Day A: worst itch day within 7 days) with the reference day (Day A-7: same weekday one week prior), assessed by conditional logistic regression including season-stratified analysis
Key secondary outcomes
1) Mean difference in Worst Itch NRS (0-10) between Day A and Day A-7
2) Proportion of participants with MCID or greater worsening of itch on Day A vs. Day A-7
3) Effect of heat-generating undergarments after adjustment for same-day factors (sweating, exercise, air conditioning use, etc.)
4) Association between undergarment brand/fit and itch severity (exploratory)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the following criteria must be met.
1) Aged 12 years or older
2) Residing in Japan
3) Provided informed consent (and parental consent for minors) after reading the study description
4) Previously diagnosed with atopic dermatitis by a physician and meeting the abbreviated UK Working Party (UKWP) diagnostic criteria for AD (by self-report)
5) Experienced at least one day with particularly severe itch within the past 7 days
Key exclusion criteria
No specific medical or ethical exclusion criteria are applied.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Horimukai |
Organization
Katsushika Medical Center, The Jikei University School of Medicine
Division name
Department of Pediatrics
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo, Japan
TEL
03-3603-2111
khorimukai@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Horimukai |
Organization
Katsushika Medical Center, The Jikei University School of Medicine
Division name
Department of Pediatrics
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo, Japan
TEL
03-3603-2111
Homepage URL
heatwise2025@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Kenta Horimukai
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of The Jikei University School of Medicine
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学葛飾医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 06 | 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
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a web-based questionnaire survey using a time-stratified case-crossover design. Participants will be recruited through the principal investigator's social media account.
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069612
