Trial Outcomes & Findings for Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules (NCT NCT00871728)
NCT ID: NCT00871728
Last Updated: 2013-07-02
Results Overview
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.
COMPLETED
PHASE4
132 participants
Baseline and Week 25
2013-07-02
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
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132
|
|
Overall Study
Treated
|
130
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Failed to Visit Hospital
|
4
|
|
Overall Study
Participant Non-compliance
|
1
|
|
Overall Study
Withdrawal of Informed Consent
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5
|
Baseline Characteristics
Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Baseline characteristics by cohort
| Measure |
Itraconazole
n=117 Participants
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.
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|---|---|
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Age Continuous
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44.6 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
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47 Participants
n=5 Participants
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Sex: Female, Male
Male
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70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 5Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
|
|---|---|
|
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
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PRIMARY outcome
Timeframe: Baseline and Week 9Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
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|---|---|
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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
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PRIMARY outcome
Timeframe: Baseline and Week 13Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Baseline and Week 25Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Baseline and Week 37Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Baseline and Week 49Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
|
|---|---|
|
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
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SECONDARY outcome
Timeframe: Week 13, 25, 37 and 49Population: 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.
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.
Outcome measures
| Measure |
Itraconazole
n=117 Participants
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.
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|---|---|
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Percentage of Participants Showing Mycological Cure
Negative KOH Smear Test : Week 13 (n=109)
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70.6 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative KOH Smear Test : Week 25 (n=103)
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83.5 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative KOH Smear Test : Week 37 (n=102)
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90.2 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative KOH Smear Test : Week 49 (n=99)
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83.8 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative BIT : Week 13 (n=108)
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64.8 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative BIT : Week 25 (n=103)
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79.6 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative BIT : Week 37 (n=102)
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81.4 percentage of participants
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Percentage of Participants Showing Mycological Cure
Negative BIT : Week 49 (n=97)
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82.5 percentage of participants
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Adverse Events
Itraconazole
Serious adverse events
| Measure |
Itraconazole
n=130 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Dyspepsia
|
0.77%
1/130 • From Screening up to 49 weeks
|
Other adverse events
| Measure |
Itraconazole
n=130 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Dyspepsia
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4.6%
6/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Constipation
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1.5%
2/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Diarrhoea
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1.5%
2/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
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0.77%
1/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Sinusitis
|
2.3%
3/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Acute tonsillitis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Genital herpes
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Infections and infestations
Paronychia
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/130 • From Screening up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sputum
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Nervous system disorders
Dizziness
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Nervous system disorders
Headache
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Nervous system disorders
Dementia
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Nervous system disorders
Somnolence
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
General disorders
Adverse event
|
2.3%
3/130 • From Screening up to 49 weeks
|
|
General disorders
Oedema peripheral
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
1.5%
2/130 • From Screening up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Renal and urinary disorders
Pyuria
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Cardiac disorders
Palpitations
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Congenital, familial and genetic disorders
Mucopolysaccharidosis
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.77%
1/130 • From Screening up to 49 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.77%
1/130 • From Screening up to 49 weeks
|
Additional Information
Clinical Research Associate
Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot provide any trial related information to external parties' without mutual agreement with the sponsor. This is valid even after the contract is canceled.
- Publication restrictions are in place
Restriction type: OTHER