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

Primary Purpose

Onychomycosis, Tinea Unguium

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tavaborole 5% Topical Solution
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Fungal infection of the nail

Eligibility Criteria

72 Months - 203 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Madera Family Medical Group
  • Stanford University School of Medicine
  • MedStar Health Research Institute - MedStar Georgetown University Hospital
  • Doctors Research Network
  • University Hospital, SUNY Downstate Medical Center
  • Skin Specialty Dermatology
  • Cyn3rgy Research
  • Oregon Dermatology & Research Center
  • West Houston Clinical Research Services LLC
  • Texas Dermatology and Laser Specialists
  • Jordan Valley Dermatology Center
  • PI Coor Clinical Research, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tavaborole 5% Topical Solution

Arm Description

All study participants apply study drug

Outcomes

Primary Outcome Measures

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).
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.
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.
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Change From Baseline in Vital Sign (Blood Pressure) at 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.
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.
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Respiratory rate was defined as the number of inspirations per minute.
Change From Baseline in Vital Sign (Respiratory Rate) at 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
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
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.
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole
Elimination Rate Constant of Tavaborole
Elimination rate constant was defined as the rate at which a drug was removed from the body.
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.
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).
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.
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.
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52

Full Information

First Posted
January 3, 2018
Last Updated
March 19, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03405818
Brief Title
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 22, 2015 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis, Tinea Unguium
Keywords
Fungal infection of the nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This was a single group study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tavaborole 5% Topical Solution
Arm Type
Experimental
Arm Description
All study participants apply study drug
Intervention Type
Drug
Intervention Name(s)
Tavaborole 5% Topical Solution
Other Intervention Name(s)
Kerydin
Intervention Description
topical solution for application to toenails
Primary Outcome Measure Information:
Title
Number of Participants With Local Tolerability Reactions by Severity
Description
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
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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)
Title
Number of Participants With Adverse Events (AEs) By Severity
Description
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)
Title
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Hematology Parameter (Hematocrit) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Hematology Parameter (Hematocrit) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Vital Sign (Blood Pressure) at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in Vital Sign (Blood Pressure) at Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Vital Sign (Pulse Rate) at Week 24
Description
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
Title
Change From Baseline in Vital Sign (Pulse Rate) at Week 52
Description
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
Title
Change From Baseline in Vital Sign (Respiratory Rate) at Week 24
Description
Respiratory rate was defined as the number of inspirations per minute.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Vital Sign (Respiratory Rate) at Week 52
Description
Respiratory rate was defined as the number of inspirations per minute.
Time Frame
Baseline, Week 52
Title
Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52
Description
Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Tavaborole
Time Frame
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Title
Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole
Time Frame
Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29
Title
Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole
Description
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
Title
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
Title
Elimination Rate Constant of Tavaborole
Description
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
Title
Elimination Half-Life of Tavaborole
Description
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
Title
Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52
Description
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
Title
Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52
Description
Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.
Time Frame
Week 24, 52
Title
Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52
Description
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
Title
Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52
Time Frame
Week 24, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
72 Months
Maximum Age & Unit of Time
203 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
MedStar Health Research Institute - MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Doctors Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University Hospital, SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Skin Specialty Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
West Houston Clinical Research Services LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
PI Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30811142
Citation
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.
Results Reference
derived

Learn more about this trial

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

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