UMIN-CTR Clinical Trial

Basic information
Public title	Study on a method for evaluating expression levels of antimicrobial peptides (AMPs) in human skin
Acronym	Evaluation method of skin AMPs
Scientific Title	Study on a method for evaluating expression levels of antimicrobial peptides (AMPs) in human skin
Scientific Title:Acronym	Evaluation method of skin AMPs
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the usefulness of method developed to evaluate expression levels of antimicrobial peptides in human skin
Basic objectives2	Others
Basic objectives -Others	Establishment of evaluation method
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Expression levels (amount) of antimicrobial peptides in samples collected from various skin sites
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	39 years-old >
Gender	Male
Key inclusion criteria	1.Informed consent provided 2.Able to follow the instruction of the study team
Key exclusion criteria	1.Subjects with injury such as wound or eczema on test sites (palms, medial forearms, medial upper arms, chest and back) 2.Subjects with severe sunburn on test sites 3.Subjects with atopic dermatitis or contact skin hypersensitivity 4.Subjects who need a routine visit to a clinic or regular medication 5.Subjects who participate in other research or treatment with physical loads that affect this test 6.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Mori
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7740
Email	mori.takuya@kao.com

Public contact
Name of contact person	1st name Shigeyuki Middle name Last name Ono
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7687
Homepage URL
Email	ono.shigeyuki@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	Faculty of sport sciences, Waseda University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human Research Ethics Committee, Kao Corporation
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-9861
Email	morisaki.naoko@kao.com

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	早稲田大学（埼玉県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 06 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	20
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	2019 Year 02 Month 20 Day
Date of IRB	2019 Year 02 Month 22 Day
Anticipated trial start date	2019 Year 03 Month 07 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 02 Month 28 Day

Other
Other related information	To confirm the usefulness of method developed to evaluate expression levels of antimicrobial peptides in human skin

Management information
Registered date	2019 Year 02 Month 28 Day
Last modified on	2020 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041055