Onychomycosis
Conditions
Keywords
Distal, Subungual onychomycosis, onychomycosis, nail fungus, Toenail fungus
Brief summary
Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.
Detailed description
A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus
Interventions
DRUGAlbaconazole 100mg
Albaconazole for 36 weeks
DRUGAlbaconazole 200mg
Albaconazole for 36 weeks
DRUGAlbaconazole 400mg
Albaconazole for 36 weeks
DRUGPlacebo 400 mg
Placebo for 36 weeks
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject aged 18 to 75 years. * Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail). * Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. * Subject is able to complete the study, comply with study instructions, and take study product orally. * Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product. * Women of childbearing potential must have a negative pregnancy test at enrollment. * Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.
Exclusion criteria
Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product): * Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study. * Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product. * Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section. * Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general. * Subject has previously participated in a clinical study with albaconazole. * Subject is not prepared to give up use of any nail cosmetic products for the duration of the study. * Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer. * Subject has any known liver disease or a history of liver toxicity with other drugs. * Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk. * Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail. * Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination. * Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years. * Female subjects who are pregnant, trying to become pregnant, or lactating. * Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Achieve Effective Treatment at Week 52 | Week 52 | At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Achieve Clinical Cure at Week 52 | Week 52 | At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. |
| The Percentage of Participants Who Achieve Mycological Cure at Week 52 | Week 52 | At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52. |
| The Percentage of Participants Who Achieve Complete Cure at Week 52 | Week 52 | At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. |
| Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | Baseline (Week 0/Day 1 or before) and up to Week 52 | Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean. |
| The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | Week 52 | A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail. |
Countries
Canada, Iceland, United States
Participant flow
Recruitment details
From 16 July 2008 to 19 February 2010, total of 582 participants with onychomycosis were randomized in 5 different arms at 26 centres in the United States, 3 centres in the Canada and 1 centre in the Iceland.
Participants by arm
| Arm | Count |
|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 116 |
| Albaconazole 400 mg (24 Weeks) Oral Weekly Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 117 |
| Albaconazole 200 mg (36 Weeks) Oral Weekly Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 117 |
| Albaconazole 100 mg (36 Weeks) Oral Weekly Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 117 |
| Placebo Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site. | 115 |
| Total | 582 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study-follow-up Phase | Adverse Event | 2 | 6 | 2 | 3 | 4 |
| Overall Study-follow-up Phase | Atrial fibrillation history | 1 | 0 | 0 | 0 | 0 |
| Overall Study-follow-up Phase | Change of location | 1 | 1 | 0 | 1 | 0 |
| Overall Study-follow-up Phase | Death | 0 | 1 | 0 | 1 | 0 |
| Overall Study-follow-up Phase | Declined to continue with follow-up | 1 | 1 | 0 | 0 | 0 |
| Overall Study-follow-up Phase | Did not met eligibility | 0 | 0 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | discontinued AE, investigator discretion | 0 | 0 | 0 | 1 | 0 |
| Overall Study-follow-up Phase | Human immunodeficiency virus positive | 0 | 0 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | Lost to Follow-up | 7 | 6 | 8 | 4 | 6 |
| Overall Study-follow-up Phase | Mis-randomized | 0 | 1 | 0 | 0 | 0 |
| Overall Study-follow-up Phase | Missing | 0 | 0 | 2 | 0 | 0 |
| Overall Study-follow-up Phase | Non-compliance | 1 | 0 | 2 | 0 | 0 |
| Overall Study-follow-up Phase | Non-compliance with study treatment | 0 | 0 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | Other Protocol violation | 0 | 0 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | Participant meets exclusion criteria | 0 | 0 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | Prohibited concomitant medication | 1 | 0 | 0 | 0 | 0 |
| Overall Study-follow-up Phase | Refused follow-up due to AE | 0 | 0 | 0 | 1 | 0 |
| Overall Study-follow-up Phase | Requested to withdraw from follow-up | 0 | 1 | 1 | 0 | 0 |
| Overall Study-follow-up Phase | Terminated due to adverse event (AE) | 0 | 0 | 0 | 0 | 1 |
| Overall Study-follow-up Phase | Use an exclusionary medication | 0 | 0 | 0 | 0 | 1 |
| Overall Study-follow-up Phase | Use of restricted medication | 0 | 1 | 0 | 0 | 0 |
| Overall Study-follow-up Phase | Withdrawal by Subject | 7 | 3 | 3 | 6 | 10 |
| Overall Study-Treatment Phase | Adverse Event | 5 | 10 | 4 | 8 | 4 |
| Overall Study-Treatment Phase | Atrial fibrillation history | 1 | 0 | 0 | 0 | 0 |
| Overall Study-Treatment Phase | Change of location | 0 | 0 | 0 | 1 | 0 |
| Overall Study-Treatment Phase | Did not met eligibility | 0 | 0 | 1 | 0 | 0 |
| Overall Study-Treatment Phase | Due to in-vitro fertilization | 0 | 0 | 0 | 1 | 0 |
| Overall Study-Treatment Phase | Human immunodeficiency virus positive | 0 | 0 | 1 | 0 | 0 |
| Overall Study-Treatment Phase | Lost to Follow-up | 4 | 5 | 6 | 4 | 4 |
| Overall Study-Treatment Phase | Misrandomized | 0 | 1 | 0 | 0 | 0 |
| Overall Study-Treatment Phase | Non-compliance with Study Treatment | 1 | 0 | 5 | 0 | 1 |
| Overall Study-Treatment Phase | Participant meets exclusion | 0 | 0 | 1 | 0 | 0 |
| Overall Study-Treatment Phase | Pregnancy | 0 | 1 | 0 | 0 | 0 |
| Overall Study-Treatment Phase | Prohibited concomitant medication | 1 | 0 | 0 | 0 | 0 |
| Overall Study-Treatment Phase | Protocol violation due to eligibility | 0 | 0 | 1 | 0 | 0 |
| Overall Study-Treatment Phase | QTCF: 454 millisecond, withdrew consent | 0 | 0 | 0 | 0 | 1 |
| Overall Study-Treatment Phase | Study drug interrupted | 0 | 1 | 0 | 0 | 0 |
| Overall Study-Treatment Phase | Use of prohibited medication | 0 | 1 | 0 | 0 | 2 |
| Overall Study-Treatment Phase | Withdrawal by Subject | 7 | 1 | 2 | 5 | 8 |
| Overall Study-Treatment Phase | Withdrew from study treatment | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Albaconazole 400 mg (36 Weeks) Oral Weekly | Total | Placebo | Albaconazole 100 mg (36 Weeks) Oral Weekly | Albaconazole 200 mg (36 Weeks) Oral Weekly | Albaconazole 400 mg (24 Weeks) Oral Weekly |
|---|---|---|---|---|---|---|
| Age, Continuous | 49.3 Years STANDARD_DEVIATION 11.4 | 48.6 Years STANDARD_DEVIATION 11.9 | 48.5 Years STANDARD_DEVIATION 12.3 | 46.8 Years STANDARD_DEVIATION 12.3 | 49.0 Years STANDARD_DEVIATION 11 | 49.2 Years STANDARD_DEVIATION 12.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 66 Participants | 13 Participants | 16 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 20 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 95 Participants | 481 Participants | 96 Participants | 93 Participants | 105 Participants | 92 Participants |
| Sex: Female, Male Female | 28 Participants | 141 Participants | 32 Participants | 33 Participants | 23 Participants | 25 Participants |
| Sex: Female, Male Male | 88 Participants | 441 Participants | 83 Participants | 84 Participants | 94 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 1 / 117 | 0 / 117 | 1 / 117 | 0 / 115 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 4 / 116 | 7 / 117 | 3 / 117 | 6 / 117 | 2 / 115 |
Outcome results
Primary
The Percentage of Participants Who Achieve Effective Treatment at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Time frame: Week 52
Population: The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Effective Treatment at Week 52 | 54 Percentage of participants |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Effective Treatment at Week 52 | 38 Percentage of participants |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Effective Treatment at Week 52 | 29 Percentage of participants |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Effective Treatment at Week 52 | 21 Percentage of participants |
| Placebo | The Percentage of Participants Who Achieve Effective Treatment at Week 52 | 1 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.
Time frame: Baseline (Week 0/Day 1 or before) and up to Week 52
Population: ITT analysis set. All participants were available at the time of assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | 6.47 Millimeters | Standard Deviation 4.62 |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | 6.21 Millimeters | Standard Deviation 4.51 |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | 4.75 Millimeters | Standard Deviation 4.58 |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | 3.78 Millimeters | Standard Deviation 4.94 |
| Placebo | Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52 | 0.40 Millimeters | Standard Deviation 3.14 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
The Percentage of Participants Who Achieve Clinical Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Time frame: Week 52
Population: ITT analysis set. All participants were available at the time of assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Clinical Cure at Week 52 | 34 Percentage of participants |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Clinical Cure at Week 52 | 32 Percentage of participants |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Clinical Cure at Week 52 | 30 Percentage of participants |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Clinical Cure at Week 52 | 16 Percentage of participants |
| Placebo | The Percentage of Participants Who Achieve Clinical Cure at Week 52 | 1 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants Who Achieve Complete Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Time frame: Week 52
Population: ITT analysis set. All participants were available at the time of assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Complete Cure at Week 52 | 33 Percentage of participants |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Complete Cure at Week 52 | 26 Percentage of participants |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Complete Cure at Week 52 | 21 Percentage of participants |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Complete Cure at Week 52 | 12 Percentage of participants |
| Placebo | The Percentage of Participants Who Achieve Complete Cure at Week 52 | 0 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants Who Achieve Mycological Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.
Time frame: Week 52
Population: ITT analysis set. All participants were available at the time of assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Mycological Cure at Week 52 | 71 Percentage of participants |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Mycological Cure at Week 52 | 54 Percentage of participants |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Mycological Cure at Week 52 | 43 Percentage of participants |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | The Percentage of Participants Who Achieve Mycological Cure at Week 52 | 34 Percentage of participants |
| Placebo | The Percentage of Participants Who Achieve Mycological Cure at Week 52 | 6 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.
Time frame: Week 52
Population: ITT analysis set. All participants were available at the time of assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albaconazole 400 mg (36 Weeks) Oral Weekly | The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | 71 Percentage of participants |
| Albaconazole 400 mg (24 Weeks) Oral Weekly | The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | 62 Percentage of participants |
| Albaconazole 200 mg (36 Weeks) Oral Weekly | The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | 61 Percentage of participants |
| Albaconazole 100 mg (36 Weeks) Oral Weekly | The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | 45 Percentage of participants |
| Placebo | The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52 | 10 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel