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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00871728
First received: February 13, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Onychomycosis, Toe
Drug: Itraconazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Change in SCIO (Scoring Clinical Index For Onychomycosis) in Toenail Onychomycosis Treating With Itraconazole Capsules

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5 [ Time Frame: Baseline and Week 5 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.

  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9 [ Time Frame: Baseline and Week 9 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.

  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.

  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25 [ Time Frame: Baseline and Week 25 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.

  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37 [ Time Frame: Baseline and Week 37 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.

  • Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49 [ Time Frame: Baseline and Week 49 ] [ Designated as safety issue: No ]
    The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.


Secondary Outcome Measures:
  • Percentage of Participants Showing Mycological Cure [ Time Frame: Week 13, 25, 37 and 49 ] [ Designated as safety issue: No ]
    Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.


Enrollment: 132
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole 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.
Other Name: Sporanox

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871728

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00871728     History of Changes
Other Study ID Numbers: CR013837, ITR-KOR-4078
Study First Received: February 13, 2009
Results First Received: April 29, 2013
Last Updated: June 24, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Onychomycosis, Toe
Itraconazole
Sporanox

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014