UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030423 |
|---|---|
| Receipt number | 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 08:43:19 |
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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
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
shoshi_keita@kaken.co.jp
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034739
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
