| 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). | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| None Burning/Stinging | | | | Mild Burning/Stinging | | | | Moderate Burning/Stinging | | |
| |
| 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. | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to 28 days after last dose of study drug (up to Week 52) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline up to 28 days after last dose of study drug (up to Week 52) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | percentage of leukocytes | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | percentage of leukocytes | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | volume percentage of red blood cells | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | volume percentage of red blood cells | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | gram per deciliter (g/dL) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | gram per deciliter (g/dL) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | International Unit per liter (IU/L) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | International Unit per liter (IU/L) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | gram per deciliter (g/dL) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | gram per deciliter (g/dL) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | millimole per liter (mmol/L) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | millimole per liter (mmol/L) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Primary | Change From Baseline in Vital Sign (Blood Pressure) at Week 52 | | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | Beats per minute (bpm) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | Beats per minute (bpm) | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 | Respiratory rate was defined as the number of inspirations per minute. | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 | Respiratory rate was defined as the number of inspirations per minute. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Number | | percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Tavaborole | | 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. | Posted | | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole | | 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. | Posted | | Median | Full Range | hour | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | hour*nanogram per milliliter (hr*ng/mL) | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole | | 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. | Posted | | Mean | Standard Deviation | hour*nanogram per milliliter (hr*ng/mL) | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Elimination Rate Constant of Tavaborole | Elimination rate constant was defined as the rate at which a drug was removed from the body. | 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. | Posted | | Mean | Standard Deviation | per hour | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | hour | | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Number | | percentage of participants | | Week 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Number | | percentage of participants | | Week 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Number | | percentage of participants | | Week 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 | | Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. | Posted | | Number | | percentage of participants | | Week 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |