Onychomycosis, Tinea Unguium
Conditions
Keywords
Fungal infection of the nail
Brief summary
This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years). Following confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period. Clinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment). A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.
Detailed description
This was an open-label study to evaluate the safety, tolerability, and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (DSO) of the toenail in pediatric subjects aged 6 to 16 years and 11 months. An eligible subject had a target great toenail (TGT) with at least 20% involvement, with a positive potassium hydroxide (KOH) wet mount and positive fungal culture for T. rubrum or T. mentagrophytes. Eligible subjects applied tavaborole 5% topical solution, once daily to all affected toenails (the TGT as well as all other toenails having the clinical characteristics of onychomycosis) throughout the 48 week treatment period. Subjects were evaluated at Screening, Baseline (Day 1), and at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 52. Each evaluation included a clinical assessment of the AEs and local tolerability evaluation. Additional procedures were performed as follows: * Mycology sampling at Screening, Week 24, and Week 52/early termination (ET); * Clinical disease severity of the TGT at Screening, Week 24, and Week 52/ET; * Safety laboratory testing at Baseline, Week 24, and Week 52/ET; In this study, there was a PK subgroup of evaluable subjects aged 12 to 16 years and 11 months studied under maximal use conditions. Subjects in this maximal use subgroup applied the study drug on all 10 toenails, including up to 2 mm of the surrounding skin, for 28 days. On Day 15, a predose PK sample was collected to assess steady state trough level. On Day 29, the study drug application was done at the study site, and PK samples were collected prior to dosing, as well as 4, 6, 8, and 24 hours postdose on Days 29 to 30.
Interventions
DRUGTavaborole 5% Topical Solution
topical solution for application to toenails
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a single group study.
Eligibility
Sex/Gender
ALL
Age
72 Months to 203 Months
Healthy volunteers
No
Inclusion criteria
* males or females, ages \>/= 6 years and \</= 16 years and 11 months * clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of the great toenails (target nail); and with positive KOH and positive culture for T. rubrum or T. mentagrophytes from either great toenail
Exclusion criteria
* the target toenail has proximal subungual onychomycosis, onychomycosis involving the nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral disease, or yellow or brown spikes, or has co-infection with certain fungi or molds * anatomic abnormalities of the toes or toenail * current or past history of chronic moccasin-type tinea pedis * current or past history of psoriasis or lichen planus * history of significant chronic fungal disease (other than onychomycosis) * diabetes * immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52 | Week 52 | Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount. |
| Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Vital Sign (Blood Pressure) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Vital Sign (Pulse Rate) at Week 24 | Baseline, Week 24 | Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes. |
| Change From Baseline in Vital Sign (Pulse Rate) at Week 52 | Baseline, Week 52 | Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes. |
| Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 | Baseline, Week 24 | Respiratory rate was defined as the number of inspirations per minute. |
| Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 | Baseline, Week 52 | Respiratory rate was defined as the number of inspirations per minute. |
| Number of Participants With Local Tolerability Reactions by Severity | Baseline up to Week 52 | Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production). |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study drug (up to Week 52) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. |
| Number of Participants With Adverse Events (AEs) By Severity | Baseline up to 28 days after last dose of study drug (up to Week 52) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort. |
| Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline, Week 24 | — |
| Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Baseline, Week 52 | — |
| Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline, Week 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | — |
| Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule. |
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | — |
| Elimination Rate Constant of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | Elimination rate constant was defined as the rate at which a drug was removed from the body. |
| Elimination Half-Life of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration. |
| Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 24, 52 | Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount). |
| Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52 | Week 24, 52 | Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail. |
| Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 24, 52 | Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis. |
| Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 | Week 24, 52 | — |
| Maximum Observed Plasma Concentration (Cmax) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kerydin Participants applied Kerydin (tavaborole) 5 percent solution, topically once daily for 48 weeks and followed up to 4 weeks after last dose of study drug. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Kerydin |
|---|---|
| Age, Continuous | 13.2 years STANDARD_DEVIATION 2.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 30 / 54 |
| serious Total, serious adverse events | 1 / 54 |
Outcome results
Primary
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline: Alanine Aminotransferase | 14.6 International Unit per liter (IU/L) | Standard Deviation 8.23 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline: Alkaline Phosphatase | 178.7 International Unit per liter (IU/L) | Standard Deviation 90.33 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline: Aspartate Aminotransferase | 21.7 International Unit per liter (IU/L) | Standard Deviation 17.6 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Change at Week 24:Alanine Aminotransferase | -1.7 International Unit per liter (IU/L) | Standard Deviation 8.21 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Change at Week 24:Alkaline Phosphatase | -1.5 International Unit per liter (IU/L) | Standard Deviation 42.81 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Change at Week 24:Aspartate Aminotransferase | -3.3 International Unit per liter (IU/L) | Standard Deviation 17.52 |
Primary
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Change at Week 52:Alanine Aminotransferase | -1.6 International Unit per liter (IU/L) | Standard Deviation 11.32 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Change at Week 52:Alkaline Phosphatase | -18.4 International Unit per liter (IU/L) | Standard Deviation 60.1 |
| Kerydin | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Change at Week 52:Aspartate Aminotransferase | -2.7 International Unit per liter (IU/L) | Standard Deviation 19.87 |
Primary
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline: Albumin | 4.49 gram per deciliter (g/dL) | Standard Deviation 0.25 |
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline: Protein | 6.94 gram per deciliter (g/dL) | Standard Deviation 0.395 |
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Change at Week 24: Albumin | -0.05 gram per deciliter (g/dL) | Standard Deviation 0.374 |
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Change at Week 24: Protein | -0.04 gram per deciliter (g/dL) | Standard Deviation 0.502 |
Primary
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Change at Week 52: Albumin | -0.08 gram per deciliter (g/dL) | Standard Deviation 0.375 |
| Kerydin | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Change at Week 52: Protein | -0.07 gram per deciliter (g/dL) | Standard Deviation 0.492 |
Primary
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline: Bilirubin | 0.46 milligram per deciliter (mg/dL) | Standard Deviation 0.279 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline: Creatinine | 0.68 milligram per deciliter (mg/dL) | Standard Deviation 0.15 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline: Glucose [non-fasting] | 87.5 milligram per deciliter (mg/dL) | Standard Deviation 11.65 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline: Urea Nitrogen | 13.5 milligram per deciliter (mg/dL) | Standard Deviation 3.12 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Change at Week 24: Bilirubin | 0.03 milligram per deciliter (mg/dL) | Standard Deviation 0.141 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Change at Week 24: Creatinine | 0.01 milligram per deciliter (mg/dL) | Standard Deviation 0.122 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Change at Week 24: Glucose [non-fasting] | 0.0 milligram per deciliter (mg/dL) | Standard Deviation 15.15 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Change at Week 24: Urea Nitrogen | -0.1 milligram per deciliter (mg/dL) | Standard Deviation 3.55 |
Primary
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Change at Week 52: Bilirubin | -0.01 milligram per deciliter (mg/dL) | Standard Deviation 0.155 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Change at Week 52: Creatinine | 0.04 milligram per deciliter (mg/dL) | Standard Deviation 0.124 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Change at Week 52: Glucose [non-fasting] | 5.9 milligram per deciliter (mg/dL) | Standard Deviation 19.61 |
| Kerydin | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Change at Week 52: Urea Nitrogen | -0.7 milligram per deciliter (mg/dL) | Standard Deviation 2.93 |
Primary
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline: Potassium | 4.25 millimole per liter (mmol/L) | Standard Deviation 0.404 |
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline: Sodium | 138.0 millimole per liter (mmol/L) | Standard Deviation 1.95 |
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Change at Week 24: Potassium | -0.05 millimole per liter (mmol/L) | Standard Deviation 0.444 |
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Change at Week 24: Sodium | 1.6 millimole per liter (mmol/L) | Standard Deviation 2.29 |
Primary
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 | Change at Week 52: Potassium | 0.00 millimole per liter (mmol/L) | Standard Deviation 0.473 |
| Kerydin | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 | Change at Week 52: Sodium | 2.1 millimole per liter (mmol/L) | Standard Deviation 2.83 |
Primary
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Baseline | 4.786 10^12 cells per liter | Standard Deviation 0.4323 |
| Kerydin | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Change at Week 24 | 0.045 10^12 cells per liter | Standard Deviation 0.2522 |
Primary
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | -0.009 10^12 cells per liter | Standard Deviation 0.2004 |
Primary
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Baseline | 42.04 volume percentage of red blood cells | Standard Deviation 3.46 |
| Kerydin | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Change at Week 24 | 0.57 volume percentage of red blood cells | Standard Deviation 2.534 |
Primary
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | -0.12 volume percentage of red blood cells | Standard Deviation 1.838 |
Primary
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Baseline | 13.79 gram per deciliter (g/dL) | Standard Deviation 1.138 |
| Kerydin | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Change at Week 24 | 0.11 gram per deciliter (g/dL) | Standard Deviation 0.65 |
Primary
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | 0.06 gram per deciliter (g/dL) | Standard Deviation 0.637 |
Primary
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline: Leukocytes | 7.11 10^9 cells per liter | Standard Deviation 1.723 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline: Platelets | 255.6 10^9 cells per liter | Standard Deviation 49.9 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Change at Week 24: Leukocytes | -0.51 10^9 cells per liter | Standard Deviation 1.716 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Change at Week 24: Platelets | -4.1 10^9 cells per liter | Standard Deviation 32.62 |
Primary
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Change at Week 52: Leukocytes | -0.62 10^9 cells per liter | Standard Deviation 1.94 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Change at Week 52: Platelets | -9.4 10^9 cells per liter | Standard Deviation 31.23 |
Primary
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline: Basophils/Leukocytes | 0.6 percentage of leukocytes | Standard Deviation 0.53 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline: Eosinophil/Leukocytes | 3.3 percentage of leukocytes | Standard Deviation 2.3 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline: Lymphocytes/Leukocytes | 34.4 percentage of leukocytes | Standard Deviation 8.89 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline: Monocytes/Leukocytes | 6.8 percentage of leukocytes | Standard Deviation 2.12 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline: Neutrophils/Leukocytes | 55.1 percentage of leukocytes | Standard Deviation 9.77 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Change at Week 24: Basophils/Leukocytes | 0.1 percentage of leukocytes | Standard Deviation 0.67 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Change at Week 24: Eosinophil/Leukocytes | -0.5 percentage of leukocytes | Standard Deviation 2.31 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Change at Week 24: Lymphocytes/Leukocytes | 1.1 percentage of leukocytes | Standard Deviation 9.34 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Change at Week 24: Monocytes/Leukocytes | -0.2 percentage of leukocytes | Standard Deviation 2 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Change at Week 24: Neutrophils/Leukocytes | -0.7 percentage of leukocytes | Standard Deviation 10.33 |
Primary
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Change at Week 52: Basophils/Leukocytes | 0.1 percentage of leukocytes | Standard Deviation 0.6 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Change at Week 52: Eosinophils/Leukocytes | 0.3 percentage of leukocytes | Standard Deviation 2.82 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Change at Week 52: Lymphocytes/Leukocytes | 0.7 percentage of leukocytes | Standard Deviation 7.91 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Change at Week 52: Monocytes/Leukocytes | -0.5 percentage of leukocytes | Standard Deviation 1.93 |
| Kerydin | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Change at Week 52: Neutrophils/Leukocytes | -0.7 percentage of leukocytes | Standard Deviation 9.64 |
Primary
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Baseline: Systolic Blood Pressure | 110.9 millimeter of mercury (mmHg) | Standard Deviation 11.65 |
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Baseline: Diastolic Blood Pressure | 68.3 millimeter of mercury (mmHg) | Standard Deviation 7.92 |
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Change at Week 24: Systolic Blood Pressure | 0.4 millimeter of mercury (mmHg) | Standard Deviation 10.02 |
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Change at Week 24: Diastolic Blood Pressure | 1.0 millimeter of mercury (mmHg) | Standard Deviation 9.34 |
Primary
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 52 | Change at Week 52: Systolic Blood Pressure | 0.1 millimeter of mercury (mmHg) | Standard Deviation 9.52 |
| Kerydin | Change From Baseline in Vital Sign (Blood Pressure) at Week 52 | Change at Week 52: Diastolic Blood Pressure | 1.0 millimeter of mercury (mmHg) | Standard Deviation 7.61 |
Primary
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Pulse Rate) at Week 24 | Baseline | 76.2 Beats per minute (bpm) | Standard Deviation 14.39 |
| Kerydin | Change From Baseline in Vital Sign (Pulse Rate) at Week 24 | Change at Week 24 | -3.0 Beats per minute (bpm) | Standard Deviation 10.49 |
Primary
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Pulse Rate) at Week 52 | -3.9 Beats per minute (bpm) | Standard Deviation 10.66 |
Primary
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Respiratory rate was defined as the number of inspirations per minute.
Time frame: Baseline, Week 24
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 | Baseline | 16.1 Breaths per minute | Standard Deviation 2.37 |
| Kerydin | Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 | Change at Week 24 | 0.2 Breaths per minute | Standard Deviation 2.62 |
Primary
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Respiratory rate was defined as the number of inspirations per minute.
Time frame: Baseline, Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 | -0.5 Breaths per minute | Standard Deviation 2.77 |
Primary
Number of Participants With Adverse Events (AEs) By Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.
Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kerydin | Number of Participants With Adverse Events (AEs) By Severity | Mild | 12 Participants |
| Kerydin | Number of Participants With Adverse Events (AEs) By Severity | Moderate | 16 Participants |
| Kerydin | Number of Participants With Adverse Events (AEs) By Severity | Severe | 2 Participants |
Primary
Number of Participants With Local Tolerability Reactions by Severity
Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).
Time frame: Baseline up to Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Burning/Stinging | 54 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Induration/Edema | 1 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Oozing and Crusting | 54 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Erythema | 2 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Burning/Stinging | 0 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Burning/Stinging | 1 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Burning/Stinging | 0 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Induration/Edema | 53 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Induration/Edema | 4 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Induration/Edema | 2 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Oozing and Crusting | 2 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Oozing and Crusting | 1 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Oozing and Crusting | 0 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Pruritus | 53 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Pruritus | 2 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Pruritus | 1 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Pruritus | 0 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Erythema | 50 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Erythema | 6 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Erythema | 0 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | None Scaling | 51 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Mild Scaling | 4 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Moderate Scaling | 3 Participants |
| Kerydin | Number of Participants With Local Tolerability Reactions by Severity | Severe Scaling | 1 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.
Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kerydin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with AEs | 30 Participants |
| Kerydin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 1 Participants |
Primary
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
Time frame: Week 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kerydin | Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52 | 8.5 percentage of participants |
Secondary
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole | 124.820 hour*nanogram per milliliter (hr*ng/mL) | Standard Deviation 73.5924 |
Secondary
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole | 102.273 hour*nanogram per milliliter (hr*ng/mL) | Standard Deviation 60.9282 |
Secondary
Elimination Half-Life of Tavaborole
Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Elimination Half-Life of Tavaborole | 9.783 hour | Standard Deviation 7.1245 |
Secondary
Elimination Rate Constant of Tavaborole
Elimination rate constant was defined as the rate at which a drug was removed from the body.
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Elimination Rate Constant of Tavaborole | 0.08528 per hour | Standard Deviation 0.024508 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kerydin | Maximum Observed Plasma Concentration (Cmax) of Tavaborole | 5.4049 Nanogram per milliliter (ng/mL) | Standard Deviation 4.32509 |
Secondary
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).
Time frame: Week 24, 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kerydin | Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 24 | 10 percentage of participants |
| Kerydin | Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 52 | 14.9 percentage of participants |
Secondary
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
Time frame: Week 24, 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kerydin | Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52 | Week 24 | 10 percentage of participants |
| Kerydin | Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52 | Week 52 | 25.5 percentage of participants |
Secondary
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.
Time frame: Week 24, 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kerydin | Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 24 | 38.0 percentage of participants |
| Kerydin | Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52 | Week 52 | 36.2 percentage of participants |
Secondary
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Time frame: Week 24, 52
Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kerydin | Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 | Week 24 | 96 percentage of participants |
| Kerydin | Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 | Week 52 | 87.2 percentage of participants |
Secondary
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Population: Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter \[mm\] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kerydin | Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole | 6.000 hour |