UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of histamine on acethylcholine-mediated sweating
Title of the study (Brief title)	The effect of histamine on sweating
Region	Japan

Condition
Condition	Healthy volunteers who were enrolled to this study after they signed an informed consent form and provided written and oral information to the study physicians.
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the effect of histamine on sweating
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) axon-reflex mediated sweating volume 2) latency time
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	Prevention
Type of intervention	Medicine
Interventions/Control_1	with or without histamine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects with signed an informed consent form and provided written and oral information to the study physicians.
Key exclusion criteria	- The part-time-service personnel, a fixed-term employment person - Whose consent was not obtained -Subjects with glaucoma, cholinergic urticaria, asthma, prostatic hypertrophy, a pregnant woman, the woman under breast-feeding -Subjects with dermatoses in a test lesion
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyuki Murota
Organization	Osaka university, School of medicine
Division name	Dermatology
Address	2-2, Yamadaoka, Suita, Osaka
TEL	0668795111
Email	h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	0668795111
Organization	Osaka univeristy
Division name	Dermatology
Address	2-2, yamadaoka, suita
TEL	0668795111
Homepage URL
Email	h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute	Dept. of dermatology, Osaka university
Institute
Department

Funding Source
Organization	Dept. of dermatology, Osaka university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 02 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 31 Day
Anticipated trial start date	2012 Year 10 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 19 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011805