The 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

NCT01007708

Run by

Dow Pharmaceutical Sciences

People needed

780

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

• Suzanne Bruce and Associates, PA The Center for Skin Research — Houston, Texas, United States
• Endeavor Clinical Trials, PA — San Antonio, Texas, United States
• Premier Clinical Research — Spokane, Washington, United States
• Madison Skin & Research, Inc. — Madison, Wisconsin, United States
• Guildford Dermatology Specialists — Surrey, British Columbia, Canada
• Dermadvances Research — Winnipeg, Manitoba, Canada
• NewLab Clinical Research — St. John's, Newfoundland and Labrador, Canada
• Lynderm Research, Inc. — Markham, Ontario, Canada
• The Centre for Dermatology & Cosmetic Surgery — Richmond Hill, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• Windsor Clinical Research — Windsor, Ontario, Canada
• Beatrice Wang, MD — Westmount, Quebec, Canada
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Impact Clinical Trials — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• Center for Clinical Research — San Francisco, California, United States
• Radiant Research — Santa Rosa, California, United States
• Colorado Medical Research Center Inc — Denver, Colorado, United States
• Ameriderm Research — Jacksonville, Florida, United States
• FXM Research Corp. — Miami, Florida, United States
• MedaPhase Inc. — Newnan, Georgia, United States
• Northwest Clinical Trials Nampa — Nampa, Idaho, United States
• DuPage Medical Group — Naperville, Illinois, United States

Full record on ClinicalTrials.gov

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