UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046760 |
|---|---|
| Receipt number | R000049920 |
| Scientific Title | Analysis of sweat gland function after sweating load in healthy subjects |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2024/08/21 14:01:59 |
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Basic information
Public title
Analysis of sweat gland function after sweating load in healthy subjects
Acronym
Analysis of sweat gland function after sweating load in healthy subjects
Scientific Title
Analysis of sweat gland function after sweating load in healthy subjects
Scientific Title:Acronym
Analysis of sweat gland function after sweating load in healthy subjects
Region
| Japan |
Condition
Condition
healthy subject
an/hypohidrosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze sweat gland function by histological and molecular biological methods using skin tissues collected from healthy individuals before and after sweating induction.
Basic objectives2
Others
Basic objectives -Others
The secondary purpose in to examine the pathological significance of sweat leakage into the dermis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological (HE staining, immunostaining, etc.) and molecular biological (PCR, in-situ hybridization, etc.) methods will be used to analyze the histological characteristics, proteins, and gene expression of the collected healthy human skin sections before and after sweating induction.
Key secondary outcomes
Histological characteristics, proteins, and gene expression of collected healthy human skin sections before and after sweat induction will be compared with tissue sections from skin disease patients (after sweat loading) and existing normal skin tissue sections (without sweat loading).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
First, skin samples are taken from either the left or right side of the abdomen before heat loading. Next, the other side of the abdomen is used to identify the sweating site using the starch-iodine method. Skin tissue is collected from the identified sweating site. The wound is sutured as appropriate and the stitches are removed after 7 days. The collected tissue should be evaluated using an appropriate method.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who are at the age from 20 to 35 years old at the time of obtaining consent.
2. Those who can obtain written consent for participation in this study.
Key exclusion criteria
1. Those who are judged inappropriate by the principal investigator or sub-investigators.
2. Patients with cholinergic urticaria, atopic dermatitis, anhidrosis, hyperhidrosis, and those with a history of such conditions, as well as patients with other skin diseases that may affect the study and those with a history of such conditions.
3. Patients who are taking drugs that affect sweating, such as drugs with anticholinergic effects.
4. Persons with a history of allergy to xylocaine, cefcapene pivoxil hydrochloride hydrate, or loxoprofen.
5. Persons with hypersensitivity to iodine, ethanol, or corn.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takahagi |
Organization
Hiroshima University
Division name
Dermatology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5238
shunstk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Yanagida |
Organization
Hiroshima University
Division name
Dermatology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5238
Homepage URL
nonzyma@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-257-5831
iryo-seisaku@office.hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049920
