UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A skin irritation study of KMW-1 in healthy adults (phase 1)
Title of the study (Brief title)	A skin irritation study of KMW-1 (phase 1)
Region	Japan

Condition
Condition	burn
Classification by specialty	Dermatology Plastic surgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate skin irritability and the safety of a single application of KMW-1 by patch test in Japanese healthy adults
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Skin irritability at 4 hours, 8 hours, 12hours, 24hours and 48 hours after administraion
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	KMW-1(0.09 g/g),Placebo, Deionized water (negative-controlled) and Patch test unit only will be applied on the back (paraspinal site) of the study subjects for 4 hours, 8 hours and 12 hours by using a closed-type patch test unit.
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	65 years-old >
Gender	Male
Key inclusion criteria	1. Health volunteers 2. Japanese 3. BMI of 18.5 to 25.0 (rounded to one decimal place)
Key exclusion criteria	1. Does NOT have dermatological diseases such as dermatitis and eczema 2. Does NOT have history of skin rash from e.g. plaster or contact dermatitis metal, cosmetics or household appliance 3. Has a wound, scar, birthmark, or tattoo on the back (paraspinal sites) 4. Has a history of allergic reactions to medications, pineapple, papaya or specific constitutions (e.g. alcohol hypersensitivity) 5. Complicated with liver, kidney, heart diseases or hematological disorders or has a history of them 6. Regularly uses drugs 7. Has a history of drug abuse (narcotics/stimulants/psychotropics) or alcohol dependence
Target sample size	20

Research contact person
Name of lead principal investigator	Nobuyuki Kodera
Organization	KAKEN PHARMACEUTICAL CO., LTD.
Division name	Clinical Development Depertment
Address	28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-5977-5111
Email	kodera_nobuyuki@kaken.co.jp

Public contact
Name of contact person	Keita Shoshi
Organization	KAKEN PHARMACEUTICAL CO., LTD.
Division name	Clinical Development Depertment
Address	28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL	03-5977-5111
Homepage URL
Email	shoshi_keita@kaken.co.jp

Sponsor
Institute	KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization	KAKEN PHARMACEUTICAL CO., LTD.
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 16 Day
Last follow-up date	2018 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 12 Month 16 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034739