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

NCT00871728 | Completed Phase 4 Results

• 2 other identifiers: CR013837ITR-KOR-4078
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Onychomycosis, Toe

Keywords

Onychomycosis, Toe; Itraconazole; Sporanox

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5

  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.

  Baseline and Week 5

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9

  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.

  Baseline and Week 9

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13

  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.

  Baseline and Week 13

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25

  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.

  Baseline and Week 25

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37

  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.

  Baseline and Week 37

• Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49

  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.

  Baseline and Week 49

Secondary Outcomes (1)

• Percentage of Participants Showing Mycological Cure

  Week 13, 25, 37 and 49

Study Arms (1)

Itraconazole

EXPERIMENTAL

Drug: Itraconazole

Interventions

Itraconazole DRUG

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.

Also known as: Sporanox

Itraconazole

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Onychomycosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

Initially it was planned to assess clinical cure rate but analysis for clinical cure rate following the administration of the study drug was replaced by change in SCIO scores which was the primary endpoint.

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea

+82-2-2094-4879

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: March 30, 2009
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2013
• Results First Posted: June 14, 2013

Record last verified: 2013-06