Clinical trial NCT00871728: Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Official title: Change in SCIO (Scoring Clinical Index For Onychomycosis) in Toenail Onychomycosis Treating With Itraconazole Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onychomycosis, Toe
Keywords: Onychomycosis, Toe
Itraconazole
Sporanox
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 after administration of itraconazole (ICZ) capsule, to identify the change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the relationship between the change of SCIO score and mycological cure rate and clinical improvement.

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 with onychomycosis. The present study consists of 2 periods: Screening period (up to Week minus 2) and Treatment period (up to Week 49). The ICZ will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally, twice daily, continuously for 1 week. Total duration of treatment will be of 49 weeks. Efficacy will primarily be evaluated by percentage of participants showing 10 percent or higher response in SCIO Score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5
timeFrame: Baseline and Week 5
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9
timeFrame: Baseline and Week 9
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13
timeFrame: Baseline and Week 13
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25
timeFrame: Baseline and Week 25
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37
timeFrame: Baseline and Week 37
measure: Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49
timeFrame: Baseline and Week 49
Secondary outcomes:
measure: Percentage of Participants Showing Mycological Cure
timeFrame: Week 13, 25, 37 and 49
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: