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CompletedNCT03405818Updated Apr 17, 2018Results posted

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

A Phase 4 interventional study of Tavaborole 5% Topical Solution in Onychomycosis and Tinea Unguium, sponsored by Pfizer. Completed at 12 sites in United States. Open to participants aged 72 Months to 203 Months. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
72 Months to 203 Months
Sex
All
01

Study summary

This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years).

Following confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period.

Clinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment).

A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.

Read the detailed description

This was an open-label study to evaluate the safety, tolerability, and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (DSO) of the toenail in pediatric subjects aged 6 to 16 years and 11 months. An eligible subject had a target great toenail (TGT) with at least 20% involvement, with a positive potassium hydroxide (KOH) wet mount and positive fungal culture for T. rubrum or T. mentagrophytes.

Eligible subjects applied tavaborole 5% topical solution, once daily to all affected toenails (the TGT as well as all other toenails having the clinical characteristics of onychomycosis) throughout the 48 week treatment period.

Subjects were evaluated at Screening, Baseline (Day 1), and at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 52. Each evaluation included a clinical assessment of the AEs and local tolerability evaluation.

Additional procedures were performed as follows:

  • Mycology sampling at Screening, Week 24, and Week 52/early termination (ET);
  • Clinical disease severity of the TGT at Screening, Week 24, and Week 52/ET;
  • Safety laboratory testing at Baseline, Week 24, and Week 52/ET;

In this study, there was a PK subgroup of evaluable subjects aged 12 to 16 years and 11 months studied under maximal use conditions. Subjects in this maximal use subgroup applied the study drug on all 10 toenails, including up to 2 mm of the surrounding skin, for 28 days. On Day 15, a predose PK sample was collected to assess steady state trough level. On Day 29, the study drug application was done at the study site, and PK samples were collected prior to dosing, as well as 4, 6, 8, and 24 hours postdose on Days 29 to 30.

02

Conditions studied

  • Onychomycosis
  • Tinea Unguium

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Keywords

  • Fungal infection of the nail
03

Who can participate

Ages eligible
72 Months to 203 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • males or females, ages >/= 6 years and \</= 16 years and 11 months
  • clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of the great toenails (target nail); and with positive KOH and positive culture for T. rubrum or T. mentagrophytes from either great toenail

Exclusion criteria

Exclusion Criteria:

  • the target toenail has proximal subungual onychomycosis, onychomycosis involving the nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral disease, or yellow or brown spikes, or has co-infection with certain fungi or molds
  • anatomic abnormalities of the toes or toenail
  • current or past history of chronic moccasin-type tinea pedis
  • current or past history of psoriasis or lichen planus
  • history of significant chronic fungal disease (other than onychomycosis)
  • diabetes
  • immunodeficiency
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Tavaborole 5% Topical Solution

    All study participants apply study drug

    Drug: Tavaborole 5% Topical Solution

Interventions

  • DrugTavaborole 5% Topical Solution

    topical solution for application to toenails

    Also known as: Kerydin

05

What researchers measure

Primary outcomes

  1. Number of Participants With Local Tolerability Reactions by Severity

    Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).

    Time frame: Baseline up to Week 52

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.

    Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)

  3. Number of Participants With Adverse Events (AEs) By Severity

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.

    Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)

  4. Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24

    Time frame: Baseline, Week 24

  5. Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52

    Time frame: Baseline, Week 52

  6. Change From Baseline in Hematology Parameter (Hematocrit) at Week 24

    Time frame: Baseline, Week 24

  7. Change From Baseline in Hematology Parameter (Hematocrit) at Week 52

    Time frame: Baseline, Week 52

  8. Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24

    Time frame: Baseline, Week 24

  9. Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52

    Time frame: Baseline, Week 52

  10. Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24

    Time frame: Baseline, Week 24

  11. Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52

    Time frame: Baseline, Week 52

  12. Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24

    Time frame: Baseline, Week 24

  13. Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52

    Time frame: Baseline, Week 52

  14. Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24

    Time frame: Baseline, Week 24

  15. Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52

    Time frame: Baseline, Week 52

  16. Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24

    Time frame: Baseline, Week 24

  17. Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52

    Time frame: Baseline, Week 52

  18. Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24

    Time frame: Baseline, Week 24

  19. Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52

    Time frame: Baseline, Week 52

  20. Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24

    Time frame: Baseline, Week 24

  21. Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52

    Time frame: Baseline, Week 52

  22. Change From Baseline in Vital Sign (Blood Pressure) at Week 24

    Time frame: Baseline, Week 24

  23. Change From Baseline in Vital Sign (Blood Pressure) at Week 52

    Time frame: Baseline, Week 52

  24. Change From Baseline in Vital Sign (Pulse Rate) at Week 24

    Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.

    Time frame: Baseline, Week 24

  25. Change From Baseline in Vital Sign (Pulse Rate) at Week 52

    Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.

    Time frame: Baseline, Week 52

  26. Change From Baseline in Vital Sign (Respiratory Rate) at Week 24

    Respiratory rate was defined as the number of inspirations per minute.

    Time frame: Baseline, Week 24

  27. Change From Baseline in Vital Sign (Respiratory Rate) at Week 52

    Respiratory rate was defined as the number of inspirations per minute.

    Time frame: Baseline, Week 52

  28. Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52

    Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.

    Time frame: Week 52

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Tavaborole

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  2. Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  3. Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole

    AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  4. Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  5. Elimination Rate Constant of Tavaborole

    Elimination rate constant was defined as the rate at which a drug was removed from the body.

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  6. Elimination Half-Life of Tavaborole

    Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.

    Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29

  7. Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52

    Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).

    Time frame: Week 24, 52

  8. Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52

    Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.

    Time frame: Week 24, 52

  9. Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52

    Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.

    Time frame: Week 24, 52

  10. Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52

    Time frame: Week 24, 52

06

Results

Posted Apr 17, 2018

Participant flow

Participant flow — Overall Study
MilestoneKerydin
Started55
Completed47
Not completed8
Withdrew: Withdrawal by subject4
Withdrew: Lost to follow-up4

Outcome measures

PrimaryNumber of Participants With Local Tolerability Reactions by Severity

Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).

Time frame:
Baseline up to Week 52
Reported as:
Count of participants · Participants
Number of Participants With Local Tolerability Reactions by Severity
ParticipantsKerydin
None Burning/Stinging54
Mild Burning/Stinging0
Moderate Burning/Stinging1
Severe Burning/Stinging0
None Induration/Edema53
Mild Induration/Edema4
Moderate Induration/Edema2
Severe Induration/Edema1
None Oozing and Crusting54
Mild Oozing and Crusting2
Moderate Oozing and Crusting1
Severe Oozing and Crusting0
None Pruritus53
Mild Pruritus2
Moderate Pruritus1
Severe Pruritus0
None Erythema50
Mild Erythema6
Moderate Erythema2
Severe Erythema0
None Scaling51
Mild Scaling4
Moderate Scaling3
Severe Scaling1
PrimaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.

Time frame:
Baseline up to 28 days after last dose of study drug (up to Week 52)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
ParticipantsKerydin
Participants with AEs30
Participants with SAEs1
PrimaryNumber of Participants With Adverse Events (AEs) By Severity

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.

Time frame:
Baseline up to 28 days after last dose of study drug (up to Week 52)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) By Severity
ParticipantsKerydin
Mild12
Moderate16
Severe2
PrimaryChange From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · percentage of leukocytes
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
percentage of leukocytesKerydin
Baseline: Basophils/Leukocytes0.6 ± 0.53
Baseline: Eosinophil/Leukocytes3.3 ± 2.30
Baseline: Lymphocytes/Leukocytes34.4 ± 8.89
Baseline: Monocytes/Leukocytes6.8 ± 2.12
Baseline: Neutrophils/Leukocytes55.1 ± 9.77
Change at Week 24: Basophils/Leukocytes0.1 ± 0.67
Change at Week 24: Eosinophil/Leukocytes-0.5 ± 2.31
Change at Week 24: Lymphocytes/Leukocytes1.1 ± 9.34
Change at Week 24: Monocytes/Leukocytes-0.2 ± 2.00
Change at Week 24: Neutrophils/Leukocytes-0.7 ± 10.33
PrimaryChange From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · percentage of leukocytes
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
percentage of leukocytesKerydin
Change at Week 52: Basophils/Leukocytes0.1 ± 0.60
Change at Week 52: Eosinophils/Leukocytes0.3 ± 2.82
Change at Week 52: Lymphocytes/Leukocytes0.7 ± 7.91
Change at Week 52: Monocytes/Leukocytes-0.5 ± 1.93
Change at Week 52: Neutrophils/Leukocytes-0.7 ± 9.64
PrimaryChange From Baseline in Hematology Parameter (Hematocrit) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · volume percentage of red blood cells
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
volume percentage of red blood cellsKerydin
Baseline42.04 ± 3.460
Change at Week 240.57 ± 2.534
PrimaryChange From Baseline in Hematology Parameter (Hematocrit) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · volume percentage of red blood cells
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
volume percentage of red blood cellsKerydin
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52-0.12 ± 1.838
PrimaryChange From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · 10^12 cells per liter
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
10^12 cells per literKerydin
Baseline4.786 ± 0.4323
Change at Week 240.045 ± 0.2522
PrimaryChange From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · 10^12 cells per liter
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
10^12 cells per literKerydin
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52-0.009 ± 0.2004
PrimaryChange From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · gram per deciliter (g/dL)
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
gram per deciliter (g/dL)Kerydin
Baseline13.79 ± 1.138
Change at Week 240.11 ± 0.650
PrimaryChange From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · gram per deciliter (g/dL)
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
gram per deciliter (g/dL)Kerydin
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 520.06 ± 0.637
PrimaryChange From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · 10^9 cells per liter
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
10^9 cells per literKerydin
Baseline: Leukocytes7.11 ± 1.723
Baseline: Platelets255.6 ± 49.90
Change at Week 24: Leukocytes-0.51 ± 1.716
Change at Week 24: Platelets-4.1 ± 32.62
PrimaryChange From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · 10^9 cells per liter
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
10^9 cells per literKerydin
Change at Week 52: Leukocytes-0.62 ± 1.940
Change at Week 52: Platelets-9.4 ± 31.23
PrimaryChange From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · International Unit per liter (IU/L)
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
International Unit per liter (IU/L)Kerydin
Baseline: Alanine Aminotransferase14.6 ± 8.23
Baseline: Alkaline Phosphatase178.7 ± 90.33
Baseline: Aspartate Aminotransferase21.7 ± 17.60
Change at Week 24:Alanine Aminotransferase-1.7 ± 8.21
Change at Week 24:Alkaline Phosphatase-1.5 ± 42.81
Change at Week 24:Aspartate Aminotransferase-3.3 ± 17.52
PrimaryChange From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · International Unit per liter (IU/L)
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
International Unit per liter (IU/L)Kerydin
Change at Week 52:Alanine Aminotransferase-1.6 ± 11.32
Change at Week 52:Alkaline Phosphatase-18.4 ± 60.10
Change at Week 52:Aspartate Aminotransferase-2.7 ± 19.87
PrimaryChange From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · gram per deciliter (g/dL)
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
gram per deciliter (g/dL)Kerydin
Baseline: Albumin4.49 ± 0.250
Baseline: Protein6.94 ± 0.395
Change at Week 24: Albumin-0.05 ± 0.374
Change at Week 24: Protein-0.04 ± 0.502
PrimaryChange From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · gram per deciliter (g/dL)
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
gram per deciliter (g/dL)Kerydin
Change at Week 52: Albumin-0.08 ± 0.375
Change at Week 52: Protein-0.07 ± 0.492
PrimaryChange From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · milligram per deciliter (mg/dL)
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
milligram per deciliter (mg/dL)Kerydin
Baseline: Bilirubin0.46 ± 0.279
Baseline: Creatinine0.68 ± 0.150
Baseline: Glucose [non-fasting]87.5 ± 11.65
Baseline: Urea Nitrogen13.5 ± 3.12
Change at Week 24: Bilirubin0.03 ± 0.141
Change at Week 24: Creatinine0.01 ± 0.122
Change at Week 24: Glucose [non-fasting]0.0 ± 15.15
Change at Week 24: Urea Nitrogen-0.1 ± 3.55
PrimaryChange From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · milligram per deciliter (mg/dL)
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
milligram per deciliter (mg/dL)Kerydin
Change at Week 52: Bilirubin-0.01 ± 0.155
Change at Week 52: Creatinine0.04 ± 0.124
Change at Week 52: Glucose [non-fasting]5.9 ± 19.61
Change at Week 52: Urea Nitrogen-0.7 ± 2.93
PrimaryChange From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · millimole per liter (mmol/L)
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
millimole per liter (mmol/L)Kerydin
Baseline: Potassium4.25 ± 0.404
Baseline: Sodium138.0 ± 1.95
Change at Week 24: Potassium-0.05 ± 0.444
Change at Week 24: Sodium1.6 ± 2.29
PrimaryChange From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · millimole per liter (mmol/L)
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
millimole per liter (mmol/L)Kerydin
Change at Week 52: Potassium0.00 ± 0.473
Change at Week 52: Sodium2.1 ± 2.83
PrimaryChange From Baseline in Vital Sign (Blood Pressure) at Week 24
Time frame:
Baseline, Week 24
Reported as:
Mean · millimeter of mercury (mmHg)
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
millimeter of mercury (mmHg)Kerydin
Baseline: Systolic Blood Pressure110.9 ± 11.65
Baseline: Diastolic Blood Pressure68.3 ± 7.92
Change at Week 24: Systolic Blood Pressure0.4 ± 10.02
Change at Week 24: Diastolic Blood Pressure1.0 ± 9.34
PrimaryChange From Baseline in Vital Sign (Blood Pressure) at Week 52
Time frame:
Baseline, Week 52
Reported as:
Mean · millimeter of mercury (mmHg)
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
millimeter of mercury (mmHg)Kerydin
Change at Week 52: Systolic Blood Pressure0.1 ± 9.52
Change at Week 52: Diastolic Blood Pressure1.0 ± 7.61
PrimaryChange From Baseline in Vital Sign (Pulse Rate) at Week 24

Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.

Time frame:
Baseline, Week 24
Reported as:
Mean · Beats per minute (bpm)
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Beats per minute (bpm)Kerydin
Baseline76.2 ± 14.39
Change at Week 24-3.0 ± 10.49
PrimaryChange From Baseline in Vital Sign (Pulse Rate) at Week 52

Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.

Time frame:
Baseline, Week 52
Reported as:
Mean · Beats per minute (bpm)
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Beats per minute (bpm)Kerydin
Change From Baseline in Vital Sign (Pulse Rate) at Week 52-3.9 ± 10.66
PrimaryChange From Baseline in Vital Sign (Respiratory Rate) at Week 24

Respiratory rate was defined as the number of inspirations per minute.

Time frame:
Baseline, Week 24
Reported as:
Mean · Breaths per minute
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Breaths per minuteKerydin
Baseline16.1 ± 2.37
Change at Week 240.2 ± 2.62
PrimaryChange From Baseline in Vital Sign (Respiratory Rate) at Week 52

Respiratory rate was defined as the number of inspirations per minute.

Time frame:
Baseline, Week 52
Reported as:
Mean · Breaths per minute
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Breaths per minuteKerydin
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52-0.5 ± 2.77
PrimaryPercentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52

Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
percentage of participantsKerydin
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 528.5
SecondaryMaximum Observed Plasma Concentration (Cmax) of Tavaborole
Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Mean · Nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Nanogram per milliliter (ng/mL)Kerydin
Maximum Observed Plasma Concentration (Cmax) of Tavaborole5.4049 ± 4.32509
SecondaryTime to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Median · hour
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
hourKerydin
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole6.000 (0.00 to 24.20)
SecondaryArea Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole

AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.

Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Mean · hour*nanogram per milliliter (hr*ng/mL)
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
hour*nanogram per milliliter (hr*ng/mL)Kerydin
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole102.273 ± 60.9282
SecondaryArea Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Mean · hour*nanogram per milliliter (hr*ng/mL)
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
hour*nanogram per milliliter (hr*ng/mL)Kerydin
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole124.820 ± 73.5924
SecondaryElimination Rate Constant of Tavaborole

Elimination rate constant was defined as the rate at which a drug was removed from the body.

Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Mean · per hour
Elimination Rate Constant of Tavaborole
per hourKerydin
Elimination Rate Constant of Tavaborole0.08528 ± 0.024508
SecondaryElimination Half-Life of Tavaborole

Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.

Time frame:
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Reported as:
Mean · hour
Elimination Half-Life of Tavaborole
hourKerydin
Elimination Half-Life of Tavaborole9.783 ± 7.1245
SecondaryPercentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52

Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).

Time frame:
Week 24, 52
Reported as:
Number · percentage of participants
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
percentage of participantsKerydin
Week 2410
Week 5214.9
SecondaryPercentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52

Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.

Time frame:
Week 24, 52
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
percentage of participantsKerydin
Week 2410
Week 5225.5
SecondaryPercentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52

Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.

Time frame:
Week 24, 52
Reported as:
Number · percentage of participants
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
percentage of participantsKerydin
Week 2438.0
Week 5236.2
SecondaryPercentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Time frame:
Week 24, 52
Reported as:
Number · percentage of participants
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
percentage of participantsKerydin
Week 2496
Week 5287.2

Adverse events

Collected over Baseline up to Week 52. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Kerydin0/54 (0%)1/54 (1.9%)30/54 (55.6%)
Most frequent serious events
Most frequent serious events
EventKerydin
AppendicitisInfections and infestations1/54
Most frequent other events
Showing 10 of 43
Most frequent other events
EventKerydin
NasopharyngitisInfections and infestations7/54
ContusionInjury, poisoning and procedural complications5/54
SinusitisInfections and infestations3/54
VomitingGastrointestinal disorders3/54
InfluenzaInfections and infestations2/54
ConcussionInjury, poisoning and procedural complications2/54
Oropharyngeal painRespiratory, thoracic and mediastinal disorders2/54
HeadacheNervous system disorders2/54
Acute sinusitisInfections and infestations1/54
ConjunctivitisInfections and infestations1/54

Baseline characteristics

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
Age, Continuous(years)Kerydin
Mean13.2 ± 2.69
Sex: Female, Male
Sex: Female, Male(Participants)Kerydin
Female17
Male37
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Kerydin
Hispanic or Latino27
Not Hispanic or Latino27
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Kerydin
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American8
White46
More than one race0
Unknown or Not Reported0
07

Study locations

12 sites
  • Madera Family Medical Group
    Madera, California 93637, United States
  • Stanford University School of Medicine
    Palo Alto, California 94304, United States
  • MedStar Health Research Institute - MedStar Georgetown University Hospital
    Washington, District of Columbia 20016, United States
  • Doctors Research Network
    South Miami, Florida 33143, United States
  • University Hospital, SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
  • Skin Specialty Dermatology
    New York, New York 10155, United States
  • Cyn3rgy Research
    Gresham, Oregon 97030, United States
  • Oregon Dermatology & Research Center
    Portland, Oregon 97210, United States
  • West Houston Clinical Research Services LLC
    Houston, Texas 77055, United States
  • Texas Dermatology and Laser Specialists
    San Antonio, Texas 78218, United States
  • Jordan Valley Dermatology Center
    West Jordan, Utah 84088, United States
  • PI Coor Clinical Research, LLC
    Burke, Virginia 22015, United States
08

References and documents

Publications

  • Rich P, Spellman M, Purohit V, Zang C, Crook TJ. Tavaborole 5% Topical Solution for the Treatment of Toenail Onychomycosis in Pediatric Patients: Results from a Phase 4 Open-Label Study. J Drugs Dermatol. 2019 Feb 1;18(2):190-195. PubMed 30811142 ↗

Study documents

  • Study protocol · Mar 28, 2016
  • Statistical analysis plan · Jun 2, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03405818
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Oct 22, 2015
Primary completion
Jul 27, 2017
Completion
Jul 27, 2017
Results posted
Apr 17, 2018
Last update
Apr 17, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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