Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Onychomycosis
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring Nail fungus, Onychomycosis, Itraconazole, Toenail
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
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
Experimental
Active Comparator
Placebo Comparator
Itraconazole tablets
Itraconazole capsules
Placebo tablets
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.