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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036336
Receipt No. R000041403
Scientific Title Analysis of sweating response after thermal stimulus
Date of disclosure of the study information 2019/04/01
Last modified on 2020/10/09

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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
Email 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
Email ymaoyama@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email 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 Enrolling by invitation
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

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041403

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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