UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001674 |
|---|---|
| Receipt number | R000002022 |
| Scientific Title | A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I) |
| Date of disclosure of the study information | 2009/01/30 |
| Last modified on | 2009/08/31 19:27:26 |
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Basic information
Public title
A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I)
Acronym
A patch test of KP-103 following single and repeated application(Phase I)
Scientific Title
A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I)
Scientific Title:Acronym
A patch test of KP-103 following single and repeated application(Phase I)
Region
| Japan |
Condition
Condition
Nail fungal infection
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For healthy adult male subjects, to evaluate skin irritancy and photosensitization of KP-103 single application by the patch test and the photopatch test. And to evaluate KP-103 and KP-103 metabolite concentration in the blood plasma. Furthermore to evaluate skin irritancy of KP-103 repeated application of seven days by the patch test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of skin irritancy,
Assessment of photosensitization,
KP-103 and KP-103 metabolite concentration in the blood plasma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To apply 0.2mL of KP-103 1% to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_2
To apply 0.2mL of KP-103 5% to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_3
To apply 0.2mL of KP-103 10% to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_4
To apply 0.2mL of KP-103 placebo to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_5
To apply 0.2mL of 0.2% sodium lauryl sulfate in deionized water to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_6
To apply 0.2mL of deionized water to the patch test unit, and apply the patch to the subjects once daily for 24 hours or seven days
Interventions/Control_7
To apply the patch test unit only to the subjects once daily for 24 hours or seven days
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) healthy adult male
(2) Age: between 20 and 65 years old
(3) The subject without dermal disease of dermatitis or eczema etc.
(4) The subject without medical history of the rash to the adhesive plaster, contact dermatitis to metal, cosmetic and household articles, or anaphylaxis to light
(5) BMI: between 18.5 and 25.0 (round off the number to one decimal place)
(6) Regarding screening examinations the results of each examined parameter must be within the standard reference range. However should a parameter deviate from the standard range and the investigator or sub investigator judge that the grade of severity is within the normal range of physiological variation and does not present a problem to the subject's safety, inclusion is also allowable.
Key exclusion criteria
(1) The subject with medical history of liver, renal, cardiac or hematologic disease corresponding over grade 2 of "Severity Criteria for Drug Adverse Reaction"
(2) The subject with medical history of allergy to drug, or idiosyncrasy (alcohol hypersensitivity etc.)
(3) The subject having been using medications regularly
(4) The subject with experience of drug dependence (narcotic drug, stimulant and psychotropic drug etc), or alcoholism
(5) The subject having used medications or the subject with the possibility of using medications within 1 week prior to the initiation of the investigational product administration
(6) The subject having took blood drawing over 400mL within 12 weeks prior, or over 200mL within 4 weeks prior, or having took ingredient blood donation within 2 weeks prior to the initiation of the investigational product administration
(7) The subject with participation in clinical trial within 16 weeks prior to the initiation of the intvesitigational product administration
(8) The subject having been proved to be positive from the result of immunological tests (HBs antigen, HCV antibody, test for syphilis, HIV antigen and antibody)
(9) The subject having been judged to be ineligible for the participation in this study by the investigator or sub investigator for any other reason
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukikuni Sakata |
Organization
Hakata Clinic
Division name
Director
Zip code
Address
Random-square 5-7F, 6-18, Tenyamachi, Hakata-ku, Hukuoka-shi, Hukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KAKEN PHARMACEUTICAL CO.,LTD.
Division name
Clinical Development Department
Zip code
Address
2-28-8, Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
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
Japan
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
| 2009 | Year | 01 | Month | 30 | 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
| 2008 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 30 | Day |
Last modified on
| 2009 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002022
