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An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03405818
Recruitment Status : Completed
First Posted : January 23, 2018
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Onychomycosis
Tinea Unguium
Intervention Drug: Tavaborole 5% Topical Solution
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Kerydin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 55
Completed 47
Not Completed 8
Reason Not Completed
Withdrawal by Subject             4
Lost to Follow-up             4
Arm/Group Title Kerydin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
13.2  (2.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
17
  31.5%
Male
37
  68.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Hispanic or Latino
27
  50.0%
Not Hispanic or Latino
27
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  14.8%
White
46
  85.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Local Tolerability Reactions by Severity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
None Burning/Stinging
54
 100.0%
Mild Burning/Stinging
0
   0.0%
Moderate Burning/Stinging
1
   1.9%
Severe Burning/Stinging
0
   0.0%
None Induration/Edema
53
  98.1%
Mild Induration/Edema
4
   7.4%
Moderate Induration/Edema
2
   3.7%
Severe Induration/Edema
1
   1.9%
None Oozing and Crusting
54
 100.0%
Mild Oozing and Crusting
2
   3.7%
Moderate Oozing and Crusting
1
   1.9%
Severe Oozing and Crusting
0
   0.0%
None Pruritus
53
  98.1%
Mild Pruritus
2
   3.7%
Moderate Pruritus
1
   1.9%
Severe Pruritus
0
   0.0%
None Erythema
50
  92.6%
Mild Erythema
6
  11.1%
Moderate Erythema
2
   3.7%
Severe Erythema
0
   0.0%
None Scaling
51
  94.4%
Mild Scaling
4
   7.4%
Moderate Scaling
3
   5.6%
Severe Scaling
1
   1.9%
2.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
30
  55.6%
Participants with SAEs
1
   1.9%
3.Primary Outcome
Title Number of Participants With Adverse Events (AEs) By Severity
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
12
  40.0%
Moderate
16
  53.3%
Severe
2
   6.7%
4.Primary Outcome
Title Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: percentage of leukocytes
Baseline: Basophils/Leukocytes Number Analyzed 49 participants
0.6  (0.53)
Baseline: Eosinophil/Leukocytes Number Analyzed 49 participants
3.3  (2.30)
Baseline: Lymphocytes/Leukocytes Number Analyzed 49 participants
34.4  (8.89)
Baseline: Monocytes/Leukocytes Number Analyzed 49 participants
6.8  (2.12)
Baseline: Neutrophils/Leukocytes Number Analyzed 49 participants
55.1  (9.77)
Change at Week 24: Basophils/Leukocytes Number Analyzed 42 participants
0.1  (0.67)
Change at Week 24: Eosinophil/Leukocytes Number Analyzed 42 participants
-0.5  (2.31)
Change at Week 24: Lymphocytes/Leukocytes Number Analyzed 42 participants
1.1  (9.34)
Change at Week 24: Monocytes/Leukocytes Number Analyzed 42 participants
-0.2  (2.00)
Change at Week 24: Neutrophils/Leukocytes Number Analyzed 42 participants
-0.7  (10.33)
5.Primary Outcome
Title Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: percentage of leukocytes
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)
6.Primary Outcome
Title Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: volume percentage of red blood cells
Baseline Number Analyzed 49 participants
42.04  (3.460)
Change at Week 24 Number Analyzed 42 participants
0.57  (2.534)
7.Primary Outcome
Title Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: volume percentage of red blood cells
-0.12  (1.838)
8.Primary Outcome
Title Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Baseline Number Analyzed 49 participants
4.786  (0.4323)
Change at Week 24 Number Analyzed 42 participants
0.045  (0.2522)
9.Primary Outcome
Title Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
-0.009  (0.2004)
10.Primary Outcome
Title Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
Baseline Number Analyzed 49 participants
13.79  (1.138)
Change at Week 24 Number Analyzed 42 participants
0.11  (0.650)
11.Primary Outcome
Title Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
0.06  (0.637)
12.Primary Outcome
Title Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Baseline: Leukocytes Number Analyzed 49 participants
7.11  (1.723)
Baseline: Platelets Number Analyzed 49 participants
255.6  (49.90)
Change at Week 24: Leukocytes Number Analyzed 42 participants
-0.51  (1.716)
Change at Week 24: Platelets Number Analyzed 42 participants
-4.1  (32.62)
13.Primary Outcome
Title Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Change at Week 52: Leukocytes -0.62  (1.940)
Change at Week 52: Platelets -9.4  (31.23)
14.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: International Unit per liter (IU/L)
Baseline: Alanine Aminotransferase Number Analyzed 54 participants
14.6  (8.23)
Baseline: Alkaline Phosphatase Number Analyzed 54 participants
178.7  (90.33)
Baseline: Aspartate Aminotransferase Number Analyzed 54 participants
21.7  (17.60)
Change at Week 24:Alanine Aminotransferase Number Analyzed 50 participants
-1.7  (8.21)
Change at Week 24:Alkaline Phosphatase Number Analyzed 50 participants
-1.5  (42.81)
Change at Week 24:Aspartate Aminotransferase Number Analyzed 50 participants
-3.3  (17.52)
15.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: International Unit per liter (IU/L)
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)
16.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
Baseline: Albumin Number Analyzed 54 participants
4.49  (0.250)
Baseline: Protein Number Analyzed 54 participants
6.94  (0.395)
Change at Week 24: Albumin Number Analyzed 50 participants
-0.05  (0.374)
Change at Week 24: Protein Number Analyzed 50 participants
-0.04  (0.502)
17.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: gram per deciliter (g/dL)
Change at Week 52: Albumin -0.08  (0.375)
Change at Week 52: Protein -0.07  (0.492)
18.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline: Bilirubin Number Analyzed 54 participants
0.46  (0.279)
Baseline: Creatinine Number Analyzed 54 participants
0.68  (0.150)
Baseline: Glucose [non-fasting] Number Analyzed 54 participants
87.5  (11.65)
Baseline: Urea Nitrogen Number Analyzed 54 participants
13.5  (3.12)
Change at Week 24: Bilirubin Number Analyzed 50 participants
0.03  (0.141)
Change at Week 24: Creatinine Number Analyzed 50 participants
0.01  (0.122)
Change at Week 24: Glucose [non-fasting] Number Analyzed 50 participants
0.0  (15.15)
Change at Week 24: Urea Nitrogen Number Analyzed 50 participants
-0.1  (3.55)
19.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
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)
20.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: millimole per liter (mmol/L)
Baseline: Potassium Number Analyzed 54 participants
4.25  (0.404)
Baseline: Sodium Number Analyzed 54 participants
138.0  (1.95)
Change at Week 24: Potassium Number Analyzed 50 participants
-0.05  (0.444)
Change at Week 24: Sodium Number Analyzed 50 participants
1.6  (2.29)
21.Primary Outcome
Title Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: millimole per liter (mmol/L)
Change at Week 52: Potassium 0.00  (0.473)
Change at Week 52: Sodium 2.1  (2.83)
22.Primary Outcome
Title Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline: Systolic Blood Pressure Number Analyzed 54 participants
110.9  (11.65)
Baseline: Diastolic Blood Pressure Number Analyzed 54 participants
68.3  (7.92)
Change at Week 24: Systolic Blood Pressure Number Analyzed 50 participants
0.4  (10.02)
Change at Week 24: Diastolic Blood Pressure Number Analyzed 50 participants
1.0  (9.34)
23.Primary Outcome
Title Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Change at Week 52: Systolic Blood Pressure 0.1  (9.52)
Change at Week 52: Diastolic Blood Pressure 1.0  (7.61)
24.Primary Outcome
Title Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
Baseline Number Analyzed 54 participants
76.2  (14.39)
Change at Week 24 Number Analyzed 50 participants
-3.0  (10.49)
25.Primary Outcome
Title Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
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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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
-3.9  (10.66)
26.Primary Outcome
Title Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Hide Description Respiratory rate was defined as the number of inspirations per minute.
Time Frame Baseline, Week 24
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Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Baseline Number Analyzed 54 participants
16.1  (2.37)
Change at Week 24 Number Analyzed 50 participants
0.2  (2.62)
27.Primary Outcome
Title Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Hide Description Respiratory rate was defined as the number of inspirations per minute.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
-0.5  (2.77)
28.Primary Outcome
Title Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
Hide Description Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
8.5
29.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Hide Description [Not Specified]
Time Frame Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
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Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
5.4049  (4.32509)
30.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Hide Description [Not Specified]
Time Frame Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
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Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: hour
6.000
(0.00 to 24.20)
31.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (hr*ng/mL)
102.273  (60.9282)
32.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Hide Description [Not Specified]
Time Frame Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (hr*ng/mL)
124.820  (73.5924)
33.Secondary Outcome
Title Elimination Rate Constant of Tavaborole
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: per hour
0.08528  (0.024508)
34.Secondary Outcome
Title Elimination Half-Life of Tavaborole
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: hour
9.783  (7.1245)
35.Secondary Outcome
Title Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 Number Analyzed 50 participants
10
Week 52 Number Analyzed 47 participants
14.9
36.Secondary Outcome
Title Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Hide Description Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 Number Analyzed 50 participants
10
Week 52 Number Analyzed 47 participants
25.5
37.Secondary Outcome
Title Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 Number Analyzed 50 participants
38.0
Week 52 Number Analyzed 47 participants
36.2
38.Secondary Outcome
Title Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Hide Description [Not Specified]
Time Frame Week 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Arm/Group Title Kerydin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 Number Analyzed 50 participants
96
Week 52 Number Analyzed 47 participants
87.2
Time Frame Baseline up to Week 52
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Adverse events were collected for safety population.
 
Arm/Group Title Kerydin
Hide Arm/Group Description 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.
All-Cause Mortality
Kerydin
Affected / at Risk (%)
Total   0/54 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Kerydin
Affected / at Risk (%)
Total   1/54 (1.85%) 
Infections and infestations   
Appendicitis * 1  1/54 (1.85%) 
1
Term from vocabulary, MedDRA 18
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Kerydin
Affected / at Risk (%)
Total   30/54 (55.56%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia * 1  1/54 (1.85%) 
Gastrointestinal disorders   
Vomiting * 1  3/54 (5.56%) 
Aphthous stomatitis * 1  1/54 (1.85%) 
Diarrhoea * 1  1/54 (1.85%) 
Nausea * 1  1/54 (1.85%) 
General disorders   
Application site erythema * 1  1/54 (1.85%) 
Immune system disorders   
Hypersensitivity * 1  1/54 (1.85%) 
Seasonal allergy * 1  1/54 (1.85%) 
Infections and infestations   
Nasopharyngitis * 1  7/54 (12.96%) 
Sinusitis * 1  3/54 (5.56%) 
Influenza * 1  2/54 (3.70%) 
Acute sinusitis * 1  1/54 (1.85%) 
Conjunctivitis * 1  1/54 (1.85%) 
Hand-foot-and-mouth disease * 1  1/54 (1.85%) 
Paronychia * 1  1/54 (1.85%) 
Pharyngitis * 1  1/54 (1.85%) 
Pilonidal cyst * 1  1/54 (1.85%) 
Respiratory tract infection * 1  1/54 (1.85%) 
Tinea pedis * 1  1/54 (1.85%) 
Tooth infection * 1  1/54 (1.85%) 
Upper respiratory tract infection * 1  1/54 (1.85%) 
Injury, poisoning and procedural complications   
Contusion * 1  5/54 (9.26%) 
Concussion * 1  2/54 (3.70%) 
Arthropod sting * 1  1/54 (1.85%) 
Eye injury * 1  1/54 (1.85%) 
Forearm fracture * 1  1/54 (1.85%) 
Limb injury * 1  1/54 (1.85%) 
Thermal burn * 1  1/54 (1.85%) 
Wound * 1  1/54 (1.85%) 
Investigations   
Blood iron decreased * 1  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion * 1  1/54 (1.85%) 
Nervous system disorders   
Headache * 1  2/54 (3.70%) 
Psychiatric disorders   
Attention deficit/hyperactivity disorder * 1  1/54 (1.85%) 
Depression * 1  1/54 (1.85%) 
Renal and urinary disorders   
Nephrotic syndrome * 1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain * 1  2/54 (3.70%) 
Asthma * 1  1/54 (1.85%) 
Cough * 1  1/54 (1.85%) 
Sinus congestion * 1  1/54 (1.85%) 
Upper respiratory tract congestion * 1  1/54 (1.85%) 
Skin and subcutaneous tissue disorders   
Acne * 1  1/54 (1.85%) 
Onychomadesis * 1  1/54 (1.85%) 
Rash generalised * 1  1/54 (1.85%) 
1
Term from vocabulary, MedDRA 18
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03405818     History of Changes
Other Study ID Numbers: TAV-ONYC-401
C3371003 ( Other Identifier: Alias Study Number )
First Submitted: January 3, 2018
First Posted: January 23, 2018
Results First Submitted: January 25, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018