Onychomycosis Clinical Trial
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
Verified date | March 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 27, 2017 |
Est. primary completion date | July 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 72 Months to 203 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital, SUNY Downstate Medical Center | Brooklyn | New York |
United States | PI Coor Clinical Research, LLC | Burke | Virginia |
United States | Cyn3rgy Research | Gresham | Oregon |
United States | West Houston Clinical Research Services LLC | Houston | Texas |
United States | Madera Family Medical Group | Madera | California |
United States | Skin Specialty Dermatology | New York | New York |
United States | Stanford University School of Medicine | Palo Alto | California |
United States | Oregon Dermatology & Research Center | Portland | Oregon |
United States | Texas Dermatology and Laser Specialists | San Antonio | Texas |
United States | Doctors Research Network | South Miami | Florida |
United States | MedStar Health Research Institute - MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | Jordan Valley Dermatology Center | West Jordan | Utah |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline up to Week 52 | |
Primary | 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. | Baseline up to 28 days after last dose of study drug (up to Week 52) | |
Primary | 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. | Baseline up to 28 days after last dose of study drug (up to Week 52) | |
Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Hematology Parameter (Hematocrit) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52 | Baseline, Week 52 | ||
Primary | Change From Baseline in Vital Sign (Blood Pressure) at Week 24 | Baseline, Week 24 | ||
Primary | Change From Baseline in Vital Sign (Blood Pressure) at Week 52 | Baseline, Week 52 | ||
Primary | 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. | Baseline, Week 24 | |
Primary | 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. | Baseline, Week 52 | |
Primary | Change From Baseline in Vital Sign (Respiratory Rate) at Week 24 | Respiratory rate was defined as the number of inspirations per minute. | Baseline, Week 24 | |
Primary | Change From Baseline in Vital Sign (Respiratory Rate) at Week 52 | Respiratory rate was defined as the number of inspirations per minute. | Baseline, Week 52 | |
Primary | 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. | Week 52 | |
Secondary | Maximum Observed Plasma Concentration (Cmax) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | ||
Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | ||
Secondary | 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. | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | |
Secondary | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | ||
Secondary | Elimination Rate Constant of Tavaborole | Elimination rate constant was defined as the rate at which a drug was removed from the body. | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | |
Secondary | 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. | Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29 | |
Secondary | 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). | Week 24, 52 | |
Secondary | 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. | Week 24, 52 | |
Secondary | 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. | Week 24, 52 | |
Secondary | Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52 | Week 24, 52 |
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