A Phase 4 interventional study of Tavaborole 5% Topical Solution in Onychomycosis and Tinea Unguium, sponsored by Pfizer. Completed at 12 sites in United States. Open to participants aged 72 Months to 203 Months. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
Among 11 studies testing tavaborole in Onychomycosis — none open to participants now, none under way, none of them phase 3. tavaborole · Onychomycosis.
Among the 11 studies testing tavaborole in Onychomycosis, this one is the 6th largest by enrollment, is the only one that started in 2015, is the only one in phase 4, and was the 11th registered.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
Browse Onychomycosis studies →None of the 11 studies testing tavaborole in Onychomycosis is open now. The open studies under Onychomycosis, anywhere →
tavaborole: first FDA approval 2014 (KERYDIN). What it is approved for, and how studies give it, is on its page →
Of the 9 Onychomycosis studies recruiting now, 3 set no upper age limit and 5 stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 72 Months to 203 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2015.
This study's enrollment of 55 is close to the median of 60 across 143 interventional studies indexed under Onychomycosis.
Median enrollment 55 across the 11 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 11 have an industry lead sponsor. The 1 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
11 studies in Onychomycosis by Pfizer: none open now, none under way, none of them phase 3. Of 11 finished, 4 (36%) have results posted.
Among the 11 studies in Onychomycosis by Pfizer, this one is the 6th largest by enrollment, is the only one that started in 2015, is the only one in phase 4, and was the 11th registered.
Pfizer’s Onychomycosis studies by the year they started, since 2005.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing tavaborole in Onychomycosis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 11 in Onychomycosis:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All study participants apply study drug
Drug: Tavaborole 5% Topical Solution
topical solution for application to toenails
Also known as: Kerydin
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
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)
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)
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Time frame: Baseline, Week 52
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
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
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
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
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
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Time frame: 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
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
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
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
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
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
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
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
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Time frame: Week 24, 52
| Milestone | Kerydin |
|---|---|
| Started | 55 |
| Completed | 47 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 4 |
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).
| Participants | Kerydin |
|---|---|
| None Burning/Stinging | 54 |
| Mild Burning/Stinging | 0 |
| Moderate Burning/Stinging | 1 |
| Severe Burning/Stinging | 0 |
| None Induration/Edema | 53 |
| Mild Induration/Edema | 4 |
| Moderate Induration/Edema | 2 |
| Severe Induration/Edema | 1 |
| None Oozing and Crusting | 54 |
| Mild Oozing and Crusting | 2 |
| Moderate Oozing and Crusting | 1 |
| Severe Oozing and Crusting | 0 |
| None Pruritus | 53 |
| Mild Pruritus | 2 |
| Moderate Pruritus | 1 |
| Severe Pruritus | 0 |
| None Erythema | 50 |
| Mild Erythema | 6 |
| Moderate Erythema | 2 |
| Severe Erythema | 0 |
| None Scaling | 51 |
| Mild Scaling | 4 |
| Moderate Scaling | 3 |
| Severe Scaling | 1 |
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.
| Participants | Kerydin |
|---|---|
| Participants with AEs | 30 |
| Participants with SAEs | 1 |
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.
| Participants | Kerydin |
|---|---|
| Mild | 12 |
| Moderate | 16 |
| Severe | 2 |
| percentage of leukocytes | Kerydin |
|---|---|
| Baseline: Basophils/Leukocytes | 0.6 ± 0.53 |
| Baseline: Eosinophil/Leukocytes | 3.3 ± 2.30 |
| Baseline: Lymphocytes/Leukocytes | 34.4 ± 8.89 |
| Baseline: Monocytes/Leukocytes | 6.8 ± 2.12 |
| Baseline: Neutrophils/Leukocytes | 55.1 ± 9.77 |
| Change at Week 24: Basophils/Leukocytes | 0.1 ± 0.67 |
| Change at Week 24: Eosinophil/Leukocytes | -0.5 ± 2.31 |
| Change at Week 24: Lymphocytes/Leukocytes | 1.1 ± 9.34 |
| Change at Week 24: Monocytes/Leukocytes | -0.2 ± 2.00 |
| Change at Week 24: Neutrophils/Leukocytes | -0.7 ± 10.33 |
| percentage of leukocytes | Kerydin |
|---|---|
| Change at Week 52: Basophils/Leukocytes | 0.1 ± 0.60 |
| Change at Week 52: Eosinophils/Leukocytes | 0.3 ± 2.82 |
| Change at Week 52: Lymphocytes/Leukocytes | 0.7 ± 7.91 |
| Change at Week 52: Monocytes/Leukocytes | -0.5 ± 1.93 |
| Change at Week 52: Neutrophils/Leukocytes | -0.7 ± 9.64 |
| volume percentage of red blood cells | Kerydin |
|---|---|
| Baseline | 42.04 ± 3.460 |
| Change at Week 24 | 0.57 ± 2.534 |
| volume percentage of red blood cells | Kerydin |
|---|---|
| Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | -0.12 ± 1.838 |
| 10^12 cells per liter | Kerydin |
|---|---|
| Baseline | 4.786 ± 0.4323 |
| Change at Week 24 | 0.045 ± 0.2522 |
| 10^12 cells per liter | Kerydin |
|---|---|
| Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | -0.009 ± 0.2004 |
| gram per deciliter (g/dL) | Kerydin |
|---|---|
| Baseline | 13.79 ± 1.138 |
| Change at Week 24 | 0.11 ± 0.650 |
| gram per deciliter (g/dL) | Kerydin |
|---|---|
| Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | 0.06 ± 0.637 |
| 10^9 cells per liter | Kerydin |
|---|---|
| Baseline: Leukocytes | 7.11 ± 1.723 |
| Baseline: Platelets | 255.6 ± 49.90 |
| Change at Week 24: Leukocytes | -0.51 ± 1.716 |
| Change at Week 24: Platelets | -4.1 ± 32.62 |
| 10^9 cells per liter | Kerydin |
|---|---|
| Change at Week 52: Leukocytes | -0.62 ± 1.940 |
| Change at Week 52: Platelets | -9.4 ± 31.23 |
| International Unit per liter (IU/L) | Kerydin |
|---|---|
| Baseline: Alanine Aminotransferase | 14.6 ± 8.23 |
| Baseline: Alkaline Phosphatase | 178.7 ± 90.33 |
| Baseline: Aspartate Aminotransferase | 21.7 ± 17.60 |
| Change at Week 24:Alanine Aminotransferase | -1.7 ± 8.21 |
| Change at Week 24:Alkaline Phosphatase | -1.5 ± 42.81 |
| Change at Week 24:Aspartate Aminotransferase | -3.3 ± 17.52 |
| International Unit per liter (IU/L) | Kerydin |
|---|---|
| Change at Week 52:Alanine Aminotransferase | -1.6 ± 11.32 |
| Change at Week 52:Alkaline Phosphatase | -18.4 ± 60.10 |
| Change at Week 52:Aspartate Aminotransferase | -2.7 ± 19.87 |
| gram per deciliter (g/dL) | Kerydin |
|---|---|
| Baseline: Albumin | 4.49 ± 0.250 |
| Baseline: Protein | 6.94 ± 0.395 |
| Change at Week 24: Albumin | -0.05 ± 0.374 |
| Change at Week 24: Protein | -0.04 ± 0.502 |
| gram per deciliter (g/dL) | Kerydin |
|---|---|
| Change at Week 52: Albumin | -0.08 ± 0.375 |
| Change at Week 52: Protein | -0.07 ± 0.492 |
| milligram per deciliter (mg/dL) | Kerydin |
|---|---|
| Baseline: Bilirubin | 0.46 ± 0.279 |
| Baseline: Creatinine | 0.68 ± 0.150 |
| Baseline: Glucose [non-fasting] | 87.5 ± 11.65 |
| Baseline: Urea Nitrogen | 13.5 ± 3.12 |
| Change at Week 24: Bilirubin | 0.03 ± 0.141 |
| Change at Week 24: Creatinine | 0.01 ± 0.122 |
| Change at Week 24: Glucose [non-fasting] | 0.0 ± 15.15 |
| Change at Week 24: Urea Nitrogen | -0.1 ± 3.55 |
| milligram per deciliter (mg/dL) | Kerydin |
|---|---|
| Change at Week 52: Bilirubin | -0.01 ± 0.155 |
| Change at Week 52: Creatinine | 0.04 ± 0.124 |
| Change at Week 52: Glucose [non-fasting] | 5.9 ± 19.61 |
| Change at Week 52: Urea Nitrogen | -0.7 ± 2.93 |
| millimole per liter (mmol/L) | Kerydin |
|---|---|
| Baseline: Potassium | 4.25 ± 0.404 |
| Baseline: Sodium | 138.0 ± 1.95 |
| Change at Week 24: Potassium | -0.05 ± 0.444 |
| Change at Week 24: Sodium | 1.6 ± 2.29 |
| millimole per liter (mmol/L) | Kerydin |
|---|---|
| Change at Week 52: Potassium | 0.00 ± 0.473 |
| Change at Week 52: Sodium | 2.1 ± 2.83 |
| millimeter of mercury (mmHg) | Kerydin |
|---|---|
| Baseline: Systolic Blood Pressure | 110.9 ± 11.65 |
| Baseline: Diastolic Blood Pressure | 68.3 ± 7.92 |
| Change at Week 24: Systolic Blood Pressure | 0.4 ± 10.02 |
| Change at Week 24: Diastolic Blood Pressure | 1.0 ± 9.34 |
| millimeter of mercury (mmHg) | Kerydin |
|---|---|
| Change at Week 52: Systolic Blood Pressure | 0.1 ± 9.52 |
| Change at Week 52: Diastolic Blood Pressure | 1.0 ± 7.61 |
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
| Beats per minute (bpm) | Kerydin |
|---|---|
| Baseline | 76.2 ± 14.39 |
| Change at Week 24 | -3.0 ± 10.49 |
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
| Beats per minute (bpm) | Kerydin |
|---|---|
| Change From Baseline in Vital Sign (Pulse Rate) at Week 52 | -3.9 ± 10.66 |
Respiratory rate was defined as the number of inspirations per minute.
| Breaths per minute | Kerydin |
|---|---|
| Baseline | 16.1 ± 2.37 |
| Change at Week 24 | 0.2 ± 2.62 |
Respiratory rate was defined as the number of inspirations per minute.
| Breaths per minute | Kerydin |
|---|---|
| Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 | -0.5 ± 2.77 |
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
| percentage of participants | Kerydin |
|---|---|
| Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52 | 8.5 |
| Nanogram per milliliter (ng/mL) | Kerydin |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Tavaborole | 5.4049 ± 4.32509 |
| hour | Kerydin |
|---|---|
| Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole | 6.000 (0.00 to 24.20) |
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.
| hour*nanogram per milliliter (hr*ng/mL) | Kerydin |
|---|---|
| Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole | 102.273 ± 60.9282 |
| hour*nanogram per milliliter (hr*ng/mL) | Kerydin |
|---|---|
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole | 124.820 ± 73.5924 |
Elimination rate constant was defined as the rate at which a drug was removed from the body.
| per hour | Kerydin |
|---|---|
| Elimination Rate Constant of Tavaborole | 0.08528 ± 0.024508 |
Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.
| hour | Kerydin |
|---|---|
| Elimination Half-Life of Tavaborole | 9.783 ± 7.1245 |
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 | Kerydin |
|---|---|
| Week 24 | 10 |
| Week 52 | 14.9 |
Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
| percentage of participants | Kerydin |
|---|---|
| Week 24 | 10 |
| Week 52 | 25.5 |
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 | Kerydin |
|---|---|
| Week 24 | 38.0 |
| Week 52 | 36.2 |
| percentage of participants | Kerydin |
|---|---|
| Week 24 | 96 |
| Week 52 | 87.2 |
Collected over Baseline up to Week 52. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kerydin | 0/54 (0%) | 1/54 (1.9%) | 30/54 (55.6%) |
| Event | Kerydin |
|---|---|
| AppendicitisInfections and infestations | 1/54 |
| Event | Kerydin |
|---|---|
| NasopharyngitisInfections and infestations | 7/54 |
| ContusionInjury, poisoning and procedural complications | 5/54 |
| SinusitisInfections and infestations | 3/54 |
| VomitingGastrointestinal disorders | 3/54 |
| InfluenzaInfections and infestations | 2/54 |
| ConcussionInjury, poisoning and procedural complications | 2/54 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/54 |
| HeadacheNervous system disorders | 2/54 |
| Acute sinusitisInfections and infestations | 1/54 |
| ConjunctivitisInfections and infestations | 1/54 |
Safety population included all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
| Age, Continuous(years) | Kerydin |
|---|---|
| Mean | 13.2 ± 2.69 |
| Sex: Female, Male(Participants) | Kerydin |
|---|---|
| Female | 17 |
| Male | 37 |
| Ethnicity (NIH/OMB)(Participants) | Kerydin |
|---|---|
| Hispanic or Latino | 27 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Kerydin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2015 to primary completion in Jul 2017, 21 months.
Results were first posted in Apr 2018, 8 months after primary completion.
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Studies of the drug tested here: Tavaborole