UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy test of II001 system
Title of the study (Brief title)	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	Hiromi Nambu
Organization	Kao Corporation
Division name	Material Science Research
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	Hiroaki Iikura
Organization	Kao Corporation
Division name	Material Science Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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