Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Completed · Phase 3

Conditions studied: Onychomycosis

In brief

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

Key facts

Study ID

NCT01008033

Run by

Dow Pharmaceutical Sciences

People needed

870

Starts

2009-11-01

Expected to finish

2011-12-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically diagnosed onychomycosis of the target nail
• Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
• Has a positive KOH examination from the target nail
• Has a positive dermatophyte culture from the target nail

You may not qualify if…

• Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
• Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
• Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Where it is running

• HOPE Research Institute — Phoenix, Arizona, United States
• Therapeutics Clinical Research — San Diego, California, United States
• University Clinical Trials, Inc — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• The Savin Center, PC — New Haven, Connecticut, United States
• Foot and Ankle Associates of Florida, Inc — Altamonte Springs, Florida, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Augusta Centre for Dermatology and Skin Renewal, LLC — Augusta, Georgia, United States
• Gwinnett Clinical Research Center, Inc. — Snellville, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Hudson Dermatology — Evansville, Indiana, United States
• Dermatology Specialists — Louisville, Kentucky, United States
• Michigan Center for Research Corp. — Clinton Township, Michigan, United States
• Academic Dermatology — Albuquerque, New Mexico, United States
• Impact Clinical Trials — New Hyde Park, New York, United States
• Radiant Research — Cinncinati, Ohio, United States
• Haber Dermatology & Cosmetic Surgery — South Euclid, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University School of Podiatric Medicine — Philadelphia, Pennsylvania, United States
• Palmetto Clinical Trial Services, LLC — Greenville, South Carolina, United States
• Rivergate Dermatology — Goodlettsville, Tennessee, United States
• University of Alabama, Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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