UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046966 |
|---|---|
| Receipt number | R000053430 |
| Scientific Title | Exploratory research on sweating disorders and their pathophysiology asteatosis asteatosis eczema |
| Date of disclosure of the study information | 2022/02/22 |
| Last modified on | 2024/11/11 11:53:10 |
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Basic information
Public title
Exploratory research on sweating disorders and their pathophysiology in asteatosis
asteatosis eczema
Acronym
Exploratory research in asteatosis
asteatosis eczema
Scientific Title
Exploratory research on sweating disorders and their pathophysiology asteatosis
asteatosis eczema
Scientific Title:Acronym
Exploratory research in asteatosis
asteatosis eczema
Region
| Japan |
Condition
Condition
asteatosis
asteatosis eczema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
study the patients mechanism for sweating disorders in patients with asteatosis
asteatosis eczema
Basic objectives2
Others
Basic objectives -Others
The interrelationship between healthy subjects and patients with asteatosis
asteatosis eczema
ebum deficiency and sebum deficiency eczema on basal sweating of the lower legs, water content of the stratum corneum, fine structure of the skin (texture), and blood flow in the dermis will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basal sweating and blood flow in healthy subjects and patients (before treatment)
Key secondary outcomes
Changes in basal sweating and blood flow after treatment in patients
Differences in stratum corneum water content, skin findings, and skin microstructure between healthy subjects and patients
Basic sweating, stratum corneum water content, skin microstructure, and blood flow in asteatosis
asteatosis eczema
difference
Basic sweating of external agents in asteatosis
asteatosis eczema
stratum corneum water content, skin microstructure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Measurement of skin ultrastructure by RSOM
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
lower leg
asteatosis
asteatosis eczema
Key exclusion criteria
Those who are applying external agents
30 years old or younger
50 years old and over
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama,Japan
TEL
0864621111
ymaoyama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
701-0192
Address
577,Matsushima,Kurashiki,Okayama,Japan
TEL
0864621111
Homepage URL
kmsrec@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima University Research Institute for Nanodevice and Biotechnology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Ethics Review Board
Address
577,Matsushima,Kurashiki,Okayama,Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 22 | 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
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 20 | Day |
Other
Other related information
October 20, 2023: Research ends
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053430
