Onychomycosis, Toe
Conditions
Keywords
Onychomycosis, Toe, Itraconazole, Sporanox
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.
Interventions
DRUGItraconazole
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
Janssen Korea, Ltd., Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13 | Baseline and 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. |
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5 | Baseline and 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. |
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9 | Baseline and 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. |
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49 | Baseline and 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. |
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25 | Baseline and 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. |
| Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37 | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Showing Mycological Cure | Week 13, 25, 37 and 49 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Itraconazole Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists 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 was 49 weeks. | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Failed to Visit Hospital | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Participant Non-compliance | 1 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Withdrawal of Informed Consent | 5 |
Baseline characteristics
| Characteristic | Itraconazole |
|---|---|
| Age Continuous | 44.6 years STANDARD_DEVIATION 10.42 |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 130 |
| serious Total, serious adverse events | 1 / 130 |
Outcome results
Primary
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.
Time frame: Baseline and Week 13
Population: The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13 | 80.3 percentage of participants |
Primary
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.
Time frame: Baseline and Week 25
Population: The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25 | 84.6 percentage of participants |
Primary
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.
Time frame: Baseline and Week 37
Population: The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37 | 86.3 percentage of participants |
Primary
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.
Time frame: Baseline and Week 49
Population: The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49 | 80.3 percentage of participants |
Primary
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.
Time frame: Baseline and Week 5
Population: The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5 | 25.6 percentage of participants |
Primary
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.
Time frame: Baseline and Week 9
Population: The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn't participate in Week 5 assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9 | 50.4 percentage of participants |
Secondary
Percentage of Participants Showing Mycological Cure
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.
Time frame: Week 13, 25, 37 and 49
Population: The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative KOH Smear Test : Week 13 (n=109) | 70.6 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative BIT : Week 49 (n=97) | 82.5 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative KOH Smear Test : Week 25 (n=103) | 83.5 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative KOH Smear Test : Week 37 (n=102) | 90.2 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative KOH Smear Test : Week 49 (n=99) | 83.8 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative BIT : Week 13 (n=108) | 64.8 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative BIT : Week 25 (n=103) | 79.6 percentage of participants |
| Itraconazole | Percentage of Participants Showing Mycological Cure | Negative BIT : Week 37 (n=102) | 81.4 percentage of participants |