UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059524 |
|---|---|
| Receipt number | R000068089 |
| Scientific Title | Research on itch sensitivity |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/23 23:40:38 |
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Basic information
Public title
Research on itch sensitivity
Acronym
Research on itch sensitivity
Scientific Title
Research on itch sensitivity
Scientific Title:Acronym
Research on itch sensitivity
Region
| Japan |
Condition
Condition
Sebum deficiency, skin disease, or diseases accompanied by itching
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify the cause of itch sensitivity, the correlation between itch levels (spontaneous itch and mechanical alloknesis) and dryness levels, and further clarify what disease factors are involved in itch sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in itch scoring with treatment
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
| Medicine |
Interventions/Control_1
Topical application of menthol (single application on dry or normal skin)
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subjects (those without skin diseases that cause itching) and those with sebum deficiency, skin diseases, or itching
Key exclusion criteria
Those with hypersensitivity to menthol or its components, areas with active lesions of dermatitis, pregnant or lactating women, etc.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Suga |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Dermatology
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
0473533111
ysuga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Uto |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Dermatology
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
TEL
0473533111
Homepage URL
m-uto@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Ethics Committee Secretariat
Address
2-1-1 Tomioka, Urayasu City, Chiba Prefecture
Tel
0473533111
rinri-urayasu@juntendo-urayasu.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
| 2025 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068089
