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Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Itraconazole 100mg capsules
Itraconazole 200mg tablets
Placebo tablets
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Nail fungus, Onychomycosis, Itraconazole, Toenail

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of onychomycosis of at least one great toenail Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit). Length of Unaffected Part of the Target Toenail ≥2mm Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail Subjects must have signed informed consent If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication. Exclusion Criteria: Onychomycosis caused by Candida spp. without the presence of a dermatophyte Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1 Use of systemic antifungals within 12 weeks prior to Visit 1 Use of topical antifungal nail lacquer within 30 days prior to Visit 1 Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1 Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF Known liver disease or a history of liver toxicity with other drugs Use of systemic immunosuppressants

Sites / Locations

  • Radiant Research -Birmingham
  • University of Alabama School of Medicine
  • Radiant Research - Tucson
  • Burke Pharmaceutical Research
  • East Bay Dermatology Medical Group Inc.
  • Skin Surgey Medical Group
  • Therapeutics Clinical Research
  • University of California
  • Radiant Research - Santa Rosa
  • Meridian Skincare
  • The Savin Center
  • Dr. Stephen Horwitz
  • International Dermatology Research Inc.
  • FMX Research Corporation
  • Advanced Dermatology and Cosmetic Surgery
  • Radiant Research - St. Petersburg
  • Radiant Research - West Palm Beach
  • Radiant Research - Atlanta West
  • Gwinnett Clinical Research Center Inc.
  • Northwest Clinical Trials
  • Radiant Research - Chicago
  • Radiant Research - Kansas City
  • Dr. David Fivenson
  • Skin and Vein Center
  • Minnesota Clinical Study Center
  • VA Medical Center
  • Dr. Eduardo Tschen
  • Skin Specialty Group
  • Columbia University Medical Center
  • Dermatology Consulting Services
  • Dermatology Clinical Research Center
  • Radiant Research - Cincinnati
  • Northwest Cutaneous Research
  • Oregon Medical Research Center
  • Rhode Island Hospital
  • Radiant Research - Anderson
  • Radiant Research - Greenville
  • Dr. J. M. Humeniuk
  • Dermatology East
  • Dermatology Associates of Knoxville
  • Tennessee Clinical Research Center
  • DermResearch Inc.
  • Dr. Terry Jones
  • Radiant Research - Dallas North
  • Dr. Stephen Miller
  • Endeavor Clinical Trials
  • Dermatology Research Center
  • South Valley Dermatology Center
  • Pariser Dermatology Specialists Ltd.
  • Radiant Research - Tacoma
  • Madison Skin and Research Inc.
  • Advanced Healthcare S. C.
  • Dr. Kirk Barber
  • Dr. Richard Thomas
  • Dr. Marc Bourcier
  • Dr. Aditja Gupta
  • Dr. Chuck Lynde
  • EntraLogix
  • Dr. Jerry Tan
  • Dr. Robert Bissonnette
  • Edifico Professional Guarionex Lopez
  • Dr. Manuel Briones
  • Centro Orquidea Blanca
  • Clinica Metropolis II
  • Langeberg Medical Centre
  • University of Cape Town
  • Dr. Z. F. Ahmed Vawda
  • DJW Navorsing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Itraconazole tablets

Itraconazole capsules

Placebo tablets

Arm Description

Itraconazole 200 mg tablets

Two Itraconazole 100 mg capsules were taken daily.

The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated.

Outcomes

Primary Outcome Measures

Clinical and Mycological Cure of Target Toenail
This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules
The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.

Secondary Outcome Measures

Clinical Improvement of the Target Toenail
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
Clinical Improvement Compared to Placebo
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.

Full Information

First Posted
July 25, 2006
Last Updated
December 16, 2016
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00356915
Brief Title
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Official Title
A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Detailed Description
Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans. The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component. Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities). Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Nail fungus, Onychomycosis, Itraconazole, Toenail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Itraconazole tablets
Arm Type
Experimental
Arm Description
Itraconazole 200 mg tablets
Arm Title
Itraconazole capsules
Arm Type
Active Comparator
Arm Description
Two Itraconazole 100 mg capsules were taken daily.
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated.
Intervention Type
Drug
Intervention Name(s)
Itraconazole 100mg capsules
Other Intervention Name(s)
Sporanox®
Intervention Description
Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit.
Intervention Type
Drug
Intervention Name(s)
Itraconazole 200mg tablets
Other Intervention Name(s)
Onmel
Intervention Description
Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Other Intervention Name(s)
placebo
Intervention Description
Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.
Primary Outcome Measure Information:
Title
Clinical and Mycological Cure of Target Toenail
Description
This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
Time Frame
1 year
Title
Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules
Description
The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator's Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical Improvement of the Target Toenail
Description
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
Time Frame
12 months
Title
Clinical Improvement Compared to Placebo
Description
Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52. The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement. 0 = Clinical Cure: No evidence of onychomycosis. 1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of onychomycosis of at least one great toenail Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit). Length of Unaffected Part of the Target Toenail ≥2mm Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail Subjects must have signed informed consent If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication. Exclusion Criteria: Onychomycosis caused by Candida spp. without the presence of a dermatophyte Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1 Use of systemic antifungals within 12 weeks prior to Visit 1 Use of topical antifungal nail lacquer within 30 days prior to Visit 1 Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1 Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF Known liver disease or a history of liver toxicity with other drugs Use of systemic immunosuppressants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research -Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
University of Alabama School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Radiant Research - Tucson
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
East Bay Dermatology Medical Group Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Skin Surgey Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0517
Country
United States
Facility Name
Radiant Research - Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Meridian Skincare
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
The Savin Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Dr. Stephen Horwitz
City
Aventure
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
International Dermatology Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
FMX Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Radiant Research - St. Petersburg
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Radiant Research - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Radiant Research - Atlanta West
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Gwinnett Clinical Research Center Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Radiant Research - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Radiant Research - Kansas City
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Dr. David Fivenson
City
Ann Arbour
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Skin and Vein Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48083
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Dr. Eduardo Tschen
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Skin Specialty Group
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Dermatology Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Radiant Research - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Northwest Cutaneous Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Radiant Research - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29617
Country
United States
Facility Name
Dr. J. M. Humeniuk
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Dermatology East
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Dermatology Associates of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Dr. Terry Jones
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Radiant Research - Dallas North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dr. Stephen Miller
City
San Antoinio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
South Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pariser Dermatology Specialists Ltd.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
235507
Country
United States
Facility Name
Radiant Research - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Madison Skin and Research Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
Facility Name
Advanced Healthcare S. C.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Dr. Kirk Barber
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S3B3
Country
Canada
Facility Name
Dr. Richard Thomas
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z3Y1
Country
Canada
Facility Name
Dr. Marc Bourcier
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C8X3
Country
Canada
Facility Name
Dr. Aditja Gupta
City
London
State/Province
Ontario
ZIP/Postal Code
N5X2P1
Country
Canada
Facility Name
Dr. Chuck Lynde
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P7N8
Country
Canada
Facility Name
EntraLogix
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6K1E1
Country
Canada
Facility Name
Dr. Jerry Tan
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W5L7
Country
Canada
Facility Name
Dr. Robert Bissonnette
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K4L5
Country
Canada
Facility Name
Edifico Professional Guarionex Lopez
City
Santo Domingo
Country
Dominican Republic
Facility Name
Dr. Manuel Briones
City
Guayaquil
Country
Ecuador
Facility Name
Centro Orquidea Blanca
City
San Pedro
State/Province
Sula
Country
Honduras
Facility Name
Clinica Metropolis II
City
Panama City
Country
Panama
Facility Name
Langeberg Medical Centre
City
Cape Town
Country
South Africa
Facility Name
University of Cape Town
City
Cape Town
Country
South Africa
Facility Name
Dr. Z. F. Ahmed Vawda
City
Durban
Country
South Africa
Facility Name
DJW Navorsing
City
Krugerson
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
23884486
Citation
Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis. J Drugs Dermatol. 2013 Jul 1;12(7):758-63.
Results Reference
derived

Learn more about this trial

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

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