Phase 4
N=55
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Onychomycosis · Tinea Unguium
Bottom Line
View on ClinicalTrials.gov: NCT03405818 ↗Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants With Local Tolerability Reactions by Severity — 54; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tavaborole 5% Topical Solution (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Tolerability Reactions by Severity |
54; 0; 1; 0; 53; 4 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
30; 1 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) By Severity |
12; 16; 2 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 |
0.6; 3.3; 34.4; 6.8; 55.1; 0.1 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 |
0.1; 0.3; 0.7; -0.5; -0.7 | — |
| PRIMARY Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 |
42.04; 0.57 | — |
| PRIMARY Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 |
-0.12 | — |
| PRIMARY Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 |
4.786; 0.045 | — |
| PRIMARY Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 |
-0.009 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 |
13.79; 0.11 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 |
0.06 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 |
7.11; 255.6; -0.51; -4.1 | — |
| PRIMARY Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 |
-0.62; -9.4 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 |
14.6; 178.7; 21.7; -1.7; -1.5; -3.3 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 |
-1.6; -18.4; -2.7 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 |
4.49; 6.94; -0.05; -0.04 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 |
-0.08; -0.07 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 |
0.46; 0.68; 87.5; 13.5; 0.03; 0.01 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 |
-0.01; 0.04; 5.9; -0.7 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 |
4.25; 138.0; -0.05; 1.6 | — |
| PRIMARY Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 |
0.00; 2.1 | — |
| PRIMARY Change From Baseline in Vital Sign (Blood Pressure) at Week 24 |
110.9; 68.3; 0.4; 1.0 | — |
| PRIMARY Change From Baseline in Vital Sign (Blood Pressure) at Week 52 |
0.1; 1.0 | — |
| PRIMARY Change From Baseline in Vital Sign (Pulse Rate) at Week 24 |
76.2; -3.0 | — |
| PRIMARY Change From Baseline in Vital Sign (Pulse Rate) at Week 52 |
-3.9 | — |
| PRIMARY Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 |
16.1; 0.2 | — |
| PRIMARY Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 |
-0.5 | — |
| PRIMARY Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52 |
8.5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Tavaborole |
5.4049 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole |
6.000 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole |
102.273 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole |
124.820 | — |
| SECONDARY Elimination Rate Constant of Tavaborole |
0.08528 | — |
| SECONDARY Elimination Half-Life of Tavaborole |
9.783 | — |
| SECONDARY Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52 |
10; 14.9 | — |
| SECONDARY Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52 |
10; 25.5 | — |
| SECONDARY Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52 |
38.0; 36.2 | — |
| SECONDARY Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 |
96; 87.2 | — |
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.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT03405818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.