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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030423
Receipt No. R000034739
Scientific Title A skin irritation study of KMW-1 in healthy adults (phase 1)
Date of disclosure of the study information 2017/12/16
Last modified on 2018/01/25

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Basic information
Public title A skin irritation study of KMW-1 in healthy adults (phase 1)
Acronym A skin irritation study of KMW-1 (phase 1)
Scientific Title A skin irritation study of KMW-1 in healthy adults (phase 1)
Scientific Title:Acronym 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
1st name
Middle name
Last name Nobuyuki Kodera
Organization KAKEN PHARMACEUTICAL CO., LTD.
Division name Clinical Development Depertment
Zip code
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
1st name
Middle name
Last name Keita Shoshi
Organization KAKEN PHARMACEUTICAL CO., LTD.
Division name Clinical Development Depertment
Zip code
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)

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
2017 Year 12 Month 16 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
2017 Year 11 Month 01 Day
Date of IRB
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

Other
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

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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