OnychomycosisPhase 4NCT03405818
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 study testing Tavaborole 5% Topical Solution in people with Onychomycosis and Tinea Unguium, run by Pfizer at 12 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 72 to 203 months
- Conditions the study is for
- Onychomycosis, Tinea Unguium
- What is being tested?
- Tavaborole 5% Topical Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 Oct 2015to 27 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 203 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University Hospital, SUNY Downstate Medical Center
Brooklyn, New York, 11203
PI Coor Clinical Research, LLC
Burke, Virginia, 22015
Cyn3rgy Research
Gresham, Oregon, 97030
West Houston Clinical Research Services LLC
Houston, Texas, 77055
Madera Family Medical Group
Madera, California, 93637
Skin Specialty Dermatology
New York, New York, 10155
Stanford University School of Medicine
Palo Alto, California, 94304
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Doctors Research Network
South Miami, Florida, 33143
MedStar Health Research Institute - MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20016
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
About this study
Official title: An Open-label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Kerydin (Registered) (Tavaborole) Topical Solution, 5% In The Treatment Of Onychomycosis Of The Toenail In Pediatric Subjects Ages 6 To 16 Years And 11 Months
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.
Read more
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.
- Conditions
- Onychomycosis, Tinea Unguium
- Being tested
- Tavaborole 5% Topical Solution
- Keywords
- Fungal infection of the nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tavaborole 5% Topical SolutionDrug
Also called Kerydin
topical solution for application to toenails
| Study group | Role | What they receive |
|---|---|---|
| Tavaborole 5% Topical Solution | Experimental | All study participants apply study drug Receives: Drug: Tavaborole 5% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.
Measured: Baseline up to 28 days after last dose of study drug (up to Week 52)
Number of Participants With Adverse Events (AEs) By Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.
Measured: Baseline up to 28 days after last dose of study drug (up to Week 52)
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Measured: Baseline, Week 52
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Measured: Baseline, Week 24
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.
Measured: Baseline, Week 52
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Respiratory rate was defined as the number of inspirations per minute.
Measured: Baseline, Week 24
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Respiratory rate was defined as the number of inspirations per minute.
Measured: Baseline, Week 52
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
Measured: Week 52
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Elimination Rate Constant of Tavaborole
Elimination rate constant was defined as the rate at which a drug was removed from the body.
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Elimination Half-Life of Tavaborole
Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.
Measured: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).
Measured: Week 24, 52
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
Measured: Week 24, 52
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.
Measured: Week 24, 52
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Measured: Week 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start22 Oct 2015
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was a single group study.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405818
- Sponsor's protocol ID
- TAV-ONYC-401
- Other IDs
- C3371003
- Status last verified
- Mar 2018
- First submitted
- 3 Jan 2018
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
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 at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Kerydin (Registered) (Tavaborole) Topical Solution, 5% In The Treatment Of Onychomycosis Of The Toenail In Pediatric Subjects Ages 6 To 16 Years And 11 Months
- ClinicalTrials.gov ID
- NCT03405818
- Acronym / sponsor ID
- TAV-ONYC-401
- Conditions
- Onychomycosis, Tinea Unguium
- Keywords
- Fungal infection of the nail
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single group study.
| Arm | Type | Receives |
|---|---|---|
| Tavaborole 5% Topical Solution | Experimental | Drug: Tavaborole 5% Topical SolutionAll study participants apply study drug |
Who may qualify
- Ages
- 72 to 203 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tavaborole 5% Topical SolutionAlso: Kerydintopical solution for application to toenails | Drug | Tavaborole 5% Topical Solution |
Primary outcome
Number of Participants With Local Tolerability Reactions by Severity
Time frame: Baseline up to Week 52
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).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)
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.
Number of Participants With Adverse Events (AEs) By Severity
Time frame: Baseline up to 28 days after last dose of study drug (up to Week 52)
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.
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Time frame: Baseline, 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.
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Time frame: Baseline, 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.
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Time frame: Baseline, Week 24
Respiratory rate was defined as the number of inspirations per minute.
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Time frame: Baseline, Week 52
Respiratory rate was defined as the number of inspirations per minute.
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
Time frame: Week 52
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Elimination Rate Constant of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Elimination Half-Life of Tavaborole
Time frame: Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Time frame: Week 24, 52
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Time frame: Week 24, 52
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Time frame: Week 24, 52
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Time frame: Week 24, 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30811142Rich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tavaborole 5% Topical Solution in people with Onychomycosis and Tinea Unguium, run by Pfizer at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Local Tolerability Reactions by Severity (time frame: Baseline up to Week 52). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.