Trial Outcomes & Findings for An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents (NCT NCT03405818)
NCT ID: NCT03405818
Last Updated: 2018-04-17
Results Overview
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).
COMPLETED
PHASE4
55 participants
Baseline up to Week 52
2018-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
47
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|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Baseline characteristics by cohort
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Age, Continuous
|
13.2 years
STANDARD_DEVIATION 2.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
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).
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Number of Participants With Local Tolerability Reactions by Severity
None Burning/Stinging
|
54 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Burning/Stinging
|
1 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Burning/Stinging
|
0 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
None Induration/Edema
|
53 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Induration/Edema
|
2 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Induration/Edema
|
1 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
None Oozing and Crusting
|
54 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Oozing and Crusting
|
1 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
None Pruritus
|
53 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Pruritus
|
2 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Pruritus
|
1 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Pruritus
|
0 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
None Erythema
|
50 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Erythema
|
6 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Erythema
|
2 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Erythema
|
0 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
None Scaling
|
51 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Scaling
|
4 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Moderate Scaling
|
3 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Scaling
|
1 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Burning/Stinging
|
0 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Induration/Edema
|
4 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Mild Oozing and Crusting
|
2 Participants
|
|
Number of Participants With Local Tolerability Reactions by Severity
Severe Oozing and Crusting
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study drug (up to Week 52)Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
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.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
30 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study drug (up to Week 52)Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, "N" signifies number of participants evaluable for this specified outcome measure.
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.
Outcome measures
| Measure |
Kerydin
n=30 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) By Severity
Mild
|
12 Participants
|
|
Number of Participants With Adverse Events (AEs) By Severity
Moderate
|
16 Participants
|
|
Number of Participants With Adverse Events (AEs) By Severity
Severe
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Baseline: Basophils/Leukocytes
|
0.6 percentage of leukocytes
Standard Deviation 0.53
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Baseline: Eosinophil/Leukocytes
|
3.3 percentage of leukocytes
Standard Deviation 2.30
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Baseline: Lymphocytes/Leukocytes
|
34.4 percentage of leukocytes
Standard Deviation 8.89
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Baseline: Monocytes/Leukocytes
|
6.8 percentage of leukocytes
Standard Deviation 2.12
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Baseline: Neutrophils/Leukocytes
|
55.1 percentage of leukocytes
Standard Deviation 9.77
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change at Week 24: Basophils/Leukocytes
|
0.1 percentage of leukocytes
Standard Deviation 0.67
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change at Week 24: Eosinophil/Leukocytes
|
-0.5 percentage of leukocytes
Standard Deviation 2.31
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change at Week 24: Lymphocytes/Leukocytes
|
1.1 percentage of leukocytes
Standard Deviation 9.34
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change at Week 24: Monocytes/Leukocytes
|
-0.2 percentage of leukocytes
Standard Deviation 2.00
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change at Week 24: Neutrophils/Leukocytes
|
-0.7 percentage of leukocytes
Standard Deviation 10.33
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=43 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change at Week 52: Basophils/Leukocytes
|
0.1 percentage of leukocytes
Standard Deviation 0.60
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change at Week 52: Eosinophils/Leukocytes
|
0.3 percentage of leukocytes
Standard Deviation 2.82
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change at Week 52: Lymphocytes/Leukocytes
|
0.7 percentage of leukocytes
Standard Deviation 7.91
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change at Week 52: Monocytes/Leukocytes
|
-0.5 percentage of leukocytes
Standard Deviation 1.93
|
|
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change at Week 52: Neutrophils/Leukocytes
|
-0.7 percentage of leukocytes
Standard Deviation 9.64
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Baseline
|
42.04 volume percentage of red blood cells
Standard Deviation 3.460
|
|
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Change at Week 24
|
0.57 volume percentage of red blood cells
Standard Deviation 2.534
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=43 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
|
-0.12 volume percentage of red blood cells
Standard Deviation 1.838
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Baseline
|
4.786 10^12 cells per liter
Standard Deviation 0.4323
|
|
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Change at Week 24
|
0.045 10^12 cells per liter
Standard Deviation 0.2522
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=43 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
|
-0.009 10^12 cells per liter
Standard Deviation 0.2004
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Baseline
|
13.79 gram per deciliter (g/dL)
Standard Deviation 1.138
|
|
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Change at Week 24
|
0.11 gram per deciliter (g/dL)
Standard Deviation 0.650
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=43 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
|
0.06 gram per deciliter (g/dL)
Standard Deviation 0.637
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Baseline: Leukocytes
|
7.11 10^9 cells per liter
Standard Deviation 1.723
|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Baseline: Platelets
|
255.6 10^9 cells per liter
Standard Deviation 49.90
|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Change at Week 24: Platelets
|
-4.1 10^9 cells per liter
Standard Deviation 32.62
|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Change at Week 24: Leukocytes
|
-0.51 10^9 cells per liter
Standard Deviation 1.716
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=43 Participants
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.
|
|---|---|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Change at Week 52: Leukocytes
|
-0.62 10^9 cells per liter
Standard Deviation 1.940
|
|
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Change at Week 52: Platelets
|
-9.4 10^9 cells per liter
Standard Deviation 31.23
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Baseline: Alanine Aminotransferase
|
14.6 International Unit per liter (IU/L)
Standard Deviation 8.23
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Baseline: Alkaline Phosphatase
|
178.7 International Unit per liter (IU/L)
Standard Deviation 90.33
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Baseline: Aspartate Aminotransferase
|
21.7 International Unit per liter (IU/L)
Standard Deviation 17.60
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Change at Week 24:Alanine Aminotransferase
|
-1.7 International Unit per liter (IU/L)
Standard Deviation 8.21
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Change at Week 24:Alkaline Phosphatase
|
-1.5 International Unit per liter (IU/L)
Standard Deviation 42.81
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Change at Week 24:Aspartate Aminotransferase
|
-3.3 International Unit per liter (IU/L)
Standard Deviation 17.52
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Change at Week 52:Alanine Aminotransferase
|
-1.6 International Unit per liter (IU/L)
Standard Deviation 11.32
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Change at Week 52:Alkaline Phosphatase
|
-18.4 International Unit per liter (IU/L)
Standard Deviation 60.10
|
|
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Change at Week 52:Aspartate Aminotransferase
|
-2.7 International Unit per liter (IU/L)
Standard Deviation 19.87
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Baseline: Albumin
|
4.49 gram per deciliter (g/dL)
Standard Deviation 0.250
|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Baseline: Protein
|
6.94 gram per deciliter (g/dL)
Standard Deviation 0.395
|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Change at Week 24: Albumin
|
-0.05 gram per deciliter (g/dL)
Standard Deviation 0.374
|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Change at Week 24: Protein
|
-0.04 gram per deciliter (g/dL)
Standard Deviation 0.502
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Change at Week 52: Albumin
|
-0.08 gram per deciliter (g/dL)
Standard Deviation 0.375
|
|
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Change at Week 52: Protein
|
-0.07 gram per deciliter (g/dL)
Standard Deviation 0.492
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Baseline: Bilirubin
|
0.46 milligram per deciliter (mg/dL)
Standard Deviation 0.279
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Baseline: Creatinine
|
0.68 milligram per deciliter (mg/dL)
Standard Deviation 0.150
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Baseline: Glucose [non-fasting]
|
87.5 milligram per deciliter (mg/dL)
Standard Deviation 11.65
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Baseline: Urea Nitrogen
|
13.5 milligram per deciliter (mg/dL)
Standard Deviation 3.12
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Change at Week 24: Bilirubin
|
0.03 milligram per deciliter (mg/dL)
Standard Deviation 0.141
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Change at Week 24: Creatinine
|
0.01 milligram per deciliter (mg/dL)
Standard Deviation 0.122
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Change at Week 24: Glucose [non-fasting]
|
0.0 milligram per deciliter (mg/dL)
Standard Deviation 15.15
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Change at Week 24: Urea Nitrogen
|
-0.1 milligram per deciliter (mg/dL)
Standard Deviation 3.55
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Change at Week 52: Bilirubin
|
-0.01 milligram per deciliter (mg/dL)
Standard Deviation 0.155
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Change at Week 52: Creatinine
|
0.04 milligram per deciliter (mg/dL)
Standard Deviation 0.124
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Change at Week 52: Glucose [non-fasting]
|
5.9 milligram per deciliter (mg/dL)
Standard Deviation 19.61
|
|
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Change at Week 52: Urea Nitrogen
|
-0.7 milligram per deciliter (mg/dL)
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Baseline: Potassium
|
4.25 millimole per liter (mmol/L)
Standard Deviation 0.404
|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Baseline: Sodium
|
138.0 millimole per liter (mmol/L)
Standard Deviation 1.95
|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Change at Week 24: Potassium
|
-0.05 millimole per liter (mmol/L)
Standard Deviation 0.444
|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Change at Week 24: Sodium
|
1.6 millimole per liter (mmol/L)
Standard Deviation 2.29
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Change at Week 52: Potassium
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.473
|
|
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Change at Week 52: Sodium
|
2.1 millimole per liter (mmol/L)
Standard Deviation 2.83
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Baseline: Systolic Blood Pressure
|
110.9 millimeter of mercury (mmHg)
Standard Deviation 11.65
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Baseline: Diastolic Blood Pressure
|
68.3 millimeter of mercury (mmHg)
Standard Deviation 7.92
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Change at Week 24: Systolic Blood Pressure
|
0.4 millimeter of mercury (mmHg)
Standard Deviation 10.02
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Change at Week 24: Diastolic Blood Pressure
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 9.34
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Change at Week 52: Systolic Blood Pressure
|
0.1 millimeter of mercury (mmHg)
Standard Deviation 9.52
|
|
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Change at Week 52: Diastolic Blood Pressure
|
1.0 millimeter of mercury (mmHg)
Standard Deviation 7.61
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Baseline
|
76.2 Beats per minute (bpm)
Standard Deviation 14.39
|
|
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Change at Week 24
|
-3.0 Beats per minute (bpm)
Standard Deviation 10.49
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
|
-3.9 Beats per minute (bpm)
Standard Deviation 10.66
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Respiratory rate was defined as the number of inspirations per minute.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Baseline
|
16.1 Breaths per minute
Standard Deviation 2.37
|
|
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Change at Week 24
|
0.2 Breaths per minute
Standard Deviation 2.62
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: 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.
Respiratory rate was defined as the number of inspirations per minute.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
|
-0.5 Breaths per minute
Standard Deviation 2.77
|
PRIMARY outcome
Timeframe: Week 52Population: 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.
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
Outcome measures
| Measure |
Kerydin
n=47 Participants
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.
|
|---|---|
|
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
Outcome measures
| Measure |
Kerydin
n=37 Participants
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.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
|
5.4049 Nanogram per milliliter (ng/mL)
Standard Deviation 4.32509
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
Outcome measures
| Measure |
Kerydin
n=36 Participants
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.
|
|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
|
6.000 hour
Interval 0.0 to 24.2
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
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.
Outcome measures
| Measure |
Kerydin
n=15 Participants
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.
|
|---|---|
|
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
|
102.273 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 60.9282
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
Outcome measures
| Measure |
Kerydin
n=15 Participants
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.
|
|---|---|
|
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
|
124.820 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 73.5924
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
Elimination rate constant was defined as the rate at which a drug was removed from the body.
Outcome measures
| Measure |
Kerydin
n=15 Participants
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.
|
|---|---|
|
Elimination Rate Constant of Tavaborole
|
0.08528 per hour
Standard Deviation 0.024508
|
SECONDARY outcome
Timeframe: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29Population: 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.
Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.
Outcome measures
| Measure |
Kerydin
n=15 Participants
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.
|
|---|---|
|
Elimination Half-Life of Tavaborole
|
9.783 hour
Standard Deviation 7.1245
|
SECONDARY outcome
Timeframe: Week 24, 52Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
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).
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Week 24
|
10 percentage of participants
|
|
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Week 52
|
14.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, 52Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Week 24
|
10 percentage of participants
|
|
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Week 52
|
25.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, 52Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
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.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Week 24
|
38.0 percentage of participants
|
|
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Week 52
|
36.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24, 52Population: Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.
Outcome measures
| Measure |
Kerydin
n=54 Participants
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.
|
|---|---|
|
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Week 24
|
96 percentage of participants
|
|
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Week 52
|
87.2 percentage of participants
|
Adverse Events
Kerydin
Serious adverse events
| Measure |
Kerydin
n=54 participants at risk
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.
|
|---|---|
|
Infections and infestations
Appendicitis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
Other adverse events
| Measure |
Kerydin
n=54 participants at risk
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.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.0%
7/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Sinusitis
|
5.6%
3/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Influenza
|
3.7%
2/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Acute sinusitis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Conjunctivitis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Paronychia
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Pilonidal cyst
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Tinea pedis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Tooth infection
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.3%
5/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Concussion
|
3.7%
2/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Wound
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
2/54 • Baseline up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Baseline up to Week 52
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.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Immune system disorders
Seasonal allergy
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Baseline up to Week 52
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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
General disorders
Application site erythema
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Investigations
Blood iron decreased
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Psychiatric disorders
Depression
|
1.9%
1/54 • Baseline up to Week 52
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.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.9%
1/54 • Baseline up to Week 52
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER