The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
- Registration Number
- NCT01007708
- Lead Sponsor
- Dow Pharmaceutical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 780
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDP-108 IDP-108 - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Percentage of patients who achieve clinical cure 52 weeks
- Secondary Outcome Measures
Name Time Method Percentage of patients who achieve clinical efficacy 52 weeks Percentage of patients who achieve mycologic cure 52 weeks
Trial Locations
- Locations (44)
K. Papp Clinical Research
🇨🇦Waterloo, Ontario, Canada
Beatrice Wang, MD
🇨🇦Westmount, Quebec, Canada
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
DermResearchCenter of New York, Inc.
🇺🇸Stony Brook, New York, United States
Suzanne Bruce and Associates, PA The Center for Skin Research
🇺🇸Houston, Texas, United States
Lynderm Research, Inc.
🇨🇦Markham, Ontario, Canada
Skin Surgery Medical Group, Inc.
🇺🇸San Diego, California, United States
FXM Research Corp.
🇺🇸Miami, Florida, United States
Endeavor Clinical Trials, PA
🇺🇸San Antonio, Texas, United States
Colorado Medical Research Center Inc
🇺🇸Denver, Colorado, United States
Dermadvances Research
🇨🇦Winnipeg, Manitoba, Canada
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
The Dermatology Group, P.C.
🇺🇸Verona, New Jersey, United States
Skin Search of Rochester, Inc
🇺🇸Rochester, New York, United States
University of North Carolina Hospitals and School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Fran E. Cook-Bolden, MD
🇺🇸New York, New York, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Oregon Medical Center, PC
🇺🇸Portland, Oregon, United States
Dermatology East
🇺🇸Germantown, Tennessee, United States
Modern Research Associates, PLLC
🇺🇸Dallas, Texas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Dermatology Specialists, Inc.
🇺🇸Oceanside, California, United States
Center for Clinical Research
🇺🇸San Francisco, California, United States
DuPage Medical Group
🇺🇸Naperville, Illinois, United States
Ameriderm Research
🇺🇸Jacksonville, Florida, United States
Northwest Clinical Trials Nampa
🇺🇸Nampa, Idaho, United States
MedaPhase Inc.
🇺🇸Newnan, Georgia, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
David Fivenson, MD, Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Brodell Medical, Inc
🇺🇸Warren, Ohio, United States
New Hanover Medical Research
🇺🇸Wilmington, North Carolina, United States
Palmetto Medical Research
🇺🇸Mt. Pleasant, South Carolina, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
DermResearch, Inc.
🇺🇸Austin, 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
NewLab Clinical Research
🇨🇦St. John's, Newfoundland and Labrador, Canada
The Centre for Dermatology & Cosmetic Surgery
🇨🇦Richmond Hill, Ontario, Canada
Windsor Clinical Research
🇨🇦Windsor, Ontario, Canada
Radiant Research
🇺🇸Santa Rosa, California, United States