Onychomycosis, Toenail Onychomychosis, Toenail Fungus. Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 1381 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Dr. Kirk Barber | Calgary | Alberta |
| Canada | Dr. Aditja Gupta | London | Ontario |
| Canada | Dr. Chuck Lynde | Markham | Ontario |
| Canada | Dr. Marc Bourcier | Moncton | New Brunswick |
| Canada | Dr. Robert Bissonnette | Montreal | Quebec |
| Canada | EntraLogix | Oakville | Ontario |
| Canada | Dr. Richard Thomas | Vancouver | British Columbia |
| Canada | Dr. Jerry Tan | Windsor | Ontario |
| Dominican Republic | Edifico Professional Guarionex Lopez | Santo Domingo | |
| Ecuador | Dr. Manuel Briones | Guayaquil | |
| Honduras | Centro Orquidea Blanca | San Pedro | Sula |
| Panama | Clinica Metropolis II | Panama City | |
| South Africa | Langeberg Medical Centre | Cape Town | |
| South Africa | University of Cape Town | Cape Town | |
| South Africa | Dr. Z. F. Ahmed Vawda | Durban | |
| South Africa | DJW Navorsing | Krugerson | |
| United States | Dr. Eduardo Tschen | Albuquerque | New Mexico |
| United States | Radiant Research - Anderson | Anderson | South Carolina |
| United States | Dr. David Fivenson | Ann Arbour | Michigan |
| United States | Radiant Research - Atlanta West | Austell | Georgia |
| United States | DermResearch Inc. | Austin | Texas |
| United States | Dr. Stephen Horwitz | Aventure | Florida |
| United States | Radiant Research -Birmingham | Birmingham | Alabama |
| United States | University of Alabama School of Medicine | Birmingham | Alabama |
| United States | Northwest Clinical Trials | Boise | Idaho |
| United States | Dr. Terry Jones | Bryan | Texas |
| United States | Radiant Research - Chicago | Chicago | Illinois |
| United States | Dermatology Clinical Research Center | Cincinnati | Ohio |
| United States | Radiant Research - Cincinnati | Cincinnati | Ohio |
| United States | Radiant Research - Dallas North | Dallas | Texas |
| United States | Meridian Skincare | Englewood | Colorado |
| United States | East Bay Dermatology Medical Group Inc. | Fremont | California |
| United States | Minnesota Clinical Study Center | Fridley | Minnesota |
| United States | Dermatology East | Germantown | Tennessee |
| United States | Radiant Research - Greenville | Greenville | South Carolina |
| United States | Dr. J. M. Humeniuk | Greer | South Carolina |
| United States | Dermatology Consulting Services | High Point | North Carolina |
| United States | Burke Pharmaceutical Research | Hot Springs | Arkansas |
| United States | Dermatology Associates of Knoxville | Knoxville | Tennessee |
| United States | Madison Skin and Research Inc. | Madison | Wisconsin |
| United States | FMX Research Corporation | Miami | Florida |
| United States | International Dermatology Research Inc. | Miami | Florida |
| United States | Advanced Healthcare S. C. | Milwaukee | Wisconsin |
| United States | VA Medical Center | Minneapolis | Minnesota |
| United States | Tennessee Clinical Research Center | Nashville | Tennessee |
| United States | The Savin Center | New Haven | Connecticut |
| United States | Columbia University Medical Center | New York | New York |
| United States | Skin Specialty Group | New York | New York |
| United States | Pariser Dermatology Specialists Ltd. | Norfolk | Virginia |
| United States | Advanced Dermatology and Cosmetic Surgery | Ormond Beach | Florida |
| United States | Radiant Research - Kansas City | Overland Park | Kansas |
| United States | Northwest Cutaneous Research | Portland | Oregon |
| United States | Oregon Medical Research Center | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Dermatology Research Center | Salt Lake City | Utah |
| United States | Dr. Stephen Miller | San Antoinio | Texas |
| United States | Endeavor Clinical Trials | San Antonio | Texas |
| United States | Skin Surgey Medical Group | San Diego | California |
| United States | Therapeutics Clinical Research | San Diego | California |
| United States | University of California | San Francisco | California |
| United States | Radiant Research - Santa Rosa | Santa Rosa | California |
| United States | Gwinnett Clinical Research Center Inc. | Snellville | Georgia |
| United States | Radiant Research - St. Petersburg | St. Petersburg | Florida |
| United States | Radiant Research - Tacoma | Tacoma | Washington |
| United States | Skin and Vein Center | Troy | Michigan |
| United States | Radiant Research - Tucson | Tuscon | Arizona |
| United States | South Valley Dermatology Center | West Jordan | Utah |
| United States | Radiant Research - West Palm Beach | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Stiefel, a GSK Company | GlaxoSmithKline |
United States, Canada, Dominican Republic, Ecuador, Honduras, Panama, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
1 year | No |
| Primary | 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. | 12 months | No |
| Secondary | 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. |
12 months | No |
| Secondary | 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. |
12 months | No |