UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001674
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

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 Japan

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.