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Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules

NCT00871728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2013-07-02

Study results available
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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.

Conditions

  • Onychomycosis, Toe

Interventions

DRUG

Itraconazole

Itraconazole (ICZ) capsule 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 and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-05-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00871728 on ClinicalTrials.gov