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

Completed · Phase 3 · Has a placebo group

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT00356915

Run by

Stiefel, a GSK Company

People needed

1381

Starts

2006-07-01

Expected to finish

2008-10-01

Last updated by the study team

2017-02-09

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama School of Medicine — Birmingham, Alabama, United States
• Radiant Research - Tucson — Tuscon, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• East Bay Dermatology Medical Group Inc. — Fremont, California, 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
• Meridian Skincare — Englewood, Colorado, United States
• The Savin Center — New Haven, Connecticut, United States
• Dr. Stephen Horwitz — Aventure, Florida, United States
• International Dermatology Research Inc. — Miami, Florida, United States
• FMX Research Corporation — Miami, Florida, United States
• Advanced Dermatology and Cosmetic Surgery — Ormond Beach, Florida, United States
• Radiant Research - St. Petersburg — St. Petersburg, Florida, United States
• Radiant Research - West Palm Beach — West Palm Beach, Florida, United States
• Radiant Research - Atlanta West — Austell, Georgia, United States
• Gwinnett Clinical Research Center Inc. — Snellville, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Radiant Research - Chicago — Chicago, Illinois, United States
• Radiant Research - Kansas City — Overland Park, Kansas, United States
• Dr. David Fivenson — Ann Arbour, Michigan, United States
• Skin and Vein Center — Troy, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Radiant Research -Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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