UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058016 |
|---|---|
| Receipt number | R000066315 |
| Scientific Title | Examination of the effects of human skin TRP channels on thermal perception |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 17:18:33 |
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Basic information
Public title
Examination of the effects of human skin TRP channels on thermal perception
Acronym
Examination of the effects of human skin TRP channels on thermal perception
Scientific Title
Examination of the effects of human skin TRP channels on thermal perception
Scientific Title:Acronym
Examination of the effects of human skin TRP channels on thermal perception
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects of TRPM8 and TRPA1 inhibition on human skin thermal perception to cold stimuli.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local skin thermal perception
Key secondary outcomes
Heart rate, blood pressure, skin blood flow, age, gender, height, weight
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
| Medicine |
Interventions/Control_1
Administration of TRPA1 and TRPM8 antagonists by intradermal microdialysis
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study will select healthy students (those without respiratory, cardiovascular, or skin diseases, and who do not take medication on a regular basis or have a history of smoking) who are interested in the content of this study and voluntarily apply in response to a public recruitment (notification to previous research collaborators).
Key exclusion criteria
Those with respiratory, circulatory, or skin disorders, those who regularly take medication, and those with a history of smoking.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
fujimoto@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Tomomi Fujimoto
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Niigata University of Health and Welfare
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel
0252574675
fujimoto@nuhw.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
Outside U.S. and Canada
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 29 | 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 | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066315
