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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034342
Receipt No. R000039079
Scientific Title Efficacy test of II001 system
Date of disclosure of the study information 2018/10/02
Last modified on 2018/11/06

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Basic information
Public title Efficacy test of II001 system
Acronym Efficacy test of II001 system
Scientific Title Efficacy test of II001 system
Scientific Title:Acronym Efficacy test of II001 system
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of II001 system for healthy adults skin protection from insects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effective contact ratlo of insects when exposed to the forearm for 5 minutes on the insect gauge
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
Other
Interventions/Control_1 One test product is applied to either the left or right forearm and the effective contact rate of the insect ismeasured. The test operation is carried out nine times, including untreated(not applied).
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
59 years-old >=
Gender Male
Key inclusion criteria Healthy adults
Key exclusion criteria -Subjects who are aware that the itch, the pain, and the swelling are awful when insects bite.
-Subjects who are aware that a insects bite remains for a long time.
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Nambu
Organization Kao Corporation
Division name Material Science Research
Zip code
Address 1334 Minato, Wakayama, Wakayama Prefecture 640-8580, JAPAN
TEL +81-73-426-5063
Email nambu.hiromi@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Iikura
Organization Kao Corporation
Division name Material Science Research
Zip code
Address 1334 Minato, Wakayama, Wakayama Prefecture 640-8580, JAPAN
TEL +81-73-426-5062
Homepage URL
Email iikura.hiroaki@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 花王株式会社(和歌山県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 02 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 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 16 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039079

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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