Status:
COMPLETED
Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Onychomycosis, Toe
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial identification test af...
Detailed Description
This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) study of ICZ in participants...
Eligibility Criteria
Inclusion
- Onychomycosis participants whose etiologic agent is identified by potassium hydroxide (KOH) smear and bacterial identification test
- Participants with Scoring Clinical Index for Onychomycosis (SCIO) greater than or equal to 9
- Participants who are healthy in general in following items: medical and medication history, physical examination before administration time, vital signs (blood pressure and pulse) and clinical laboratory tests (clinical test results \[liver function and renal function\] are within 2 times the normal range)
- Female participants of child-bearing age who use acceptable contraceptives
- Participants who can understand features of clinical study and signed informed consent form
Exclusion
- Participants with psoriasis (scaly skin rash)
- Diabetic participants who take an anti-diabetic drug
- Pregnant or breast feeding female participants
- Participants with clinical evidence of arterial insufficiency or peripheral vascular disease and medical history of decreased ventricular function like congestive heart failure (heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body)
- Participants who applied a topical antifungal agent (nail lacquer) on target nail within 1 month before the study medication administration and who took an oral antifungal agent within 3 month before the study medication administration
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00871728
Start Date
January 1 2007
End Date
December 1 2009
Last Update
July 2 2013
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