Clinical trial NCT00356915: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Nail fungus
Onychomycosis
Itraconazole
Toenail
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-07-27
Enrollment: 1381
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical and Mycological Cure of Target Toenail
timeFrame: 1 year
measure: Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Improvement of the Target Toenail
timeFrame: 12 months
measure: Clinical Improvement Compared to Placebo
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research -Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama School of Medicine
state: Alabama
city: Tuscon
country: United States
facility: Radiant Research - Tucson
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Fremont
country: United States
facility: East Bay Dermatology Medical Group Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgey Medical Group
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Santa Rosa
country: United States
facility: Radiant Research - Santa Rosa
state: California
city: Englewood
country: United States
facility: Meridian Skincare
state: Colorado
city: New Haven
country: United States
facility: The Savin Center
state: Connecticut
city: Aventure
country: United States
facility: Dr. Stephen Horwitz
state: Florida
city: Miami
country: United States
facility: International Dermatology Research Inc.
state: Florida
city: Miami
country: United States
facility: FMX Research Corporation
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: St. Petersburg
country: United States
facility: Radiant Research - St. Petersburg
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research - West Palm Beach
state: Florida
city: Austell
country: United States
facility: Radiant Research - Atlanta West
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center Inc.
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Radiant Research - Chicago
state: Illinois
city: Overland Park
country: United States
facility: Radiant Research - Kansas City
state: Kansas
city: Ann Arbour
country: United States
facility: Dr. David Fivenson
state: Michigan
city: Troy
country: United States
facility: Skin and Vein Center
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
city: Albuquerque
country: United States
facility: Dr. Eduardo Tschen
state: New Mexico
city: New York
country: United States
facility: Skin Specialty Group
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Cincinnati
country: United States
facility: Dermatology Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research - Cincinnati
state: Ohio
city: Portland
country: United States
facility: Northwest Cutaneous Research
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research - Anderson
state: South Carolina
city: Greenville
country: United States
facility: Radiant Research - Greenville
state: South Carolina
city: Greer
country: United States
facility: Dr. J. M. Humeniuk
state: South Carolina
city: Germantown
country: United States
facility: Dermatology East
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Bryan
country: United States
facility: Dr. Terry Jones
state: Texas
city: Dallas
country: United States
facility: Radiant Research - Dallas North
state: Texas
city: San Antoinio
country: United States
facility: Dr. Stephen Miller
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: West Jordan
country: United States
facility: South Valley Dermatology Center
state: Utah
city: Norfolk
country: United States
facility: Pariser Dermatology Specialists Ltd.
state: Virginia
city: Tacoma
country: United States
facility: Radiant Research - Tacoma
state: Washington
city: Madison
country: United States
facility: Madison Skin and Research Inc.
state: Wisconsin
city: Milwaukee
country: United States
facility: Advanced Healthcare S. C.
state: Wisconsin
city: Calgary
country: Canada
facility: Dr. Kirk Barber
state: Alberta
city: Vancouver
country: Canada
facility: Dr. Richard Thomas
state: British Columbia
city: Moncton
country: Canada
facility: Dr. Marc Bourcier
state: New Brunswick
city: London
country: Canada
facility: Dr. Aditja Gupta
state: Ontario
city: Markham
country: Canada
facility: Dr. Chuck Lynde
state: Ontario
city: Oakville
country: Canada
facility: EntraLogix
state: Ontario
city: Windsor
country: Canada
facility: Dr. Jerry Tan
state: Ontario
city: Montreal
country: Canada
facility: Dr. Robert Bissonnette
state: Quebec
city: Santo Domingo
country: Dominican Republic
facility: Edifico Professional Guarionex Lopez
city: Guayaquil
country: Ecuador
facility: Dr. Manuel Briones
city: San Pedro
country: Honduras
facility: Centro Orquidea Blanca
state: Sula
city: Panama City
country: Panama
facility: Clinica Metropolis II
city: Cape Town
country: South Africa
facility: Langeberg Medical Centre
city: Cape Town
country: South Africa
facility: University of Cape Town
city: Durban
country: South Africa
facility: Dr. Z. F. Ahmed Vawda
city: Krugerson
country: South Africa
facility: DJW Navorsing
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.