UMIN-CTR Clinical Trial

Basic information
Public title	A parallel group study about the influence which warmed humidification has on nasal mucosa in healthy adult
Acronym	Study about the influence which heated humidification has on nasal mucosa
Scientific Title	A parallel group study about the influence which warmed humidification has on nasal mucosa in healthy adult
Scientific Title:Acronym	Study about the influence which heated humidification has on nasal mucosa
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The fundamental knowledge about the infection prevention and environmental normalization by the heated humidification to a nasal cavity is acquired.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Qualitative and quantitive analysis of the bacteria in nasal mucus
Key secondary outcomes	Quantitive analysis of antimicrobial peptide and evaluation of antimicrobial activity in nasal mucus

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	The humidification cup A is applied twice per day while two weeks
Interventions/Control_2	The humidification cup B is applied twice per day while two weeks
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	60 years-old >
Gender	Male
Key inclusion criteria	1)The healthy man who detects specific bacteria from nasal mucus
Key exclusion criteria	1)Subjects who have a skin disorder to the test product wearing part 2)Subjects who have the skin allergy condition over drugs, cosmetics, a commercial mask, and warm temperature 3)Subjects who have merged diabetes mellitus
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hideshi Oda
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	03-5630-7271
Email	oda.hideshi@kao.com

Public contact
1st name of contact person	1st name Middle name Last name Shigemi Tsuchiya
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code
Address	2-1-3, Bunka Sumida-ku, Tokyo
TEL	03-5630-7271
Homepage URL
Email	tsuchiya.shigemi@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 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	Completed
Date of protocol fixation	2018 Year 01 Month 15 Day
Date of IRB	2018 Year 01 Month 29 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2018 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	2018 Year 03 Month 27 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036447