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)

UMIN ID: UMIN000001674

Registered date:30/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Nail fungal infection
• Date of first enrollment: 2009/02/01
• Target sample size: 56
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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
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
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
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
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
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
To apply the patch test unit only to the subjects once daily for 24 hours or seven days

Outcome(s)

• Primary Outcome: Assessment of skin irritancy, Assessment of photosensitization, KP-103 and KP-103 metabolite concentration in the blood plasma

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male
• Exclude 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

Related Information

• Primary Sponsor: KAKEN PHARMACEUTICAL CO.,LTD.
• Source(s) of Monetary Support: KAKEN PHARMACEUTICAL CO.,LTD.