UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036336 |
|---|---|
| Receipt number | R000041403 |
| Scientific Title | Analysis of sweating response after thermal stimulus |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/06/07 16:03:30 |
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Basic information
Public title
Analysis of sweating response after thermal stimulus
Acronym
Analysis of sweating response after thermal stimulus
Scientific Title
Analysis of sweating response after thermal stimulus
Scientific Title:Acronym
Analysis of sweating response after thermal stimulus
Region
| Japan |
Condition
Condition
Healthy control, cases with sweating disorder,cases with palmoplantar hyperkeratosis
Classification by specialty
| Dermatology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of a sweating response before (basal, insensible sweating) and after thermal stimulus (inducible, sensible sweating)
Basic objectives2
Others
Basic objectives -Others
Skin surface hydration and amount of sebum
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of a sweating response before and after thermal stimulation and/or acetylcholine by impression mold technique, starch-iodine test(Minor's sweat test),capsule type sweating-evaporation ratemeter.
Key secondary outcomes
Skin surface hydration, texture, amount of sebum and temperature.
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
Sweating test
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
| 10 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Person who agree to participate in this trial. 2. Person with sweat disturbance, palmoplantar hyperkeratosis and healty peoples without sweat disturbance.
Key exclusion criteria
Person who disagree to participate in this trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Aoyama |
Organization
Kawasaki Medical School
Division name
Dermatology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
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
Dermatology
Zip code
700-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
ymaoyama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development(AMED), Grant-in -Aide for sicentific research, and Kawasaki medical school
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of kawasaki medical school and hospital
Address
577, Matsushima, Kurashiki, Okayama, Japan
Tel
086-462-1111
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Monitoring conducted on November 18, 2020
Monitoring conducted on May 24, 2021
Monitoring conducted on January 21, 2022
Monitoring will not be conducted as there are no entries as of June 21, 2022.
Monitoring will not be conducted as there are no entries as of December 11, 2023.
Monitoring ended on June 7, 2024. No problems.
Management information
Registered date
| 2019 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041403
