Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
- Registration Number
- NCT01008033
- 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
- 870
- 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 (64)
Temple University School of Podiatric Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
University Clinical Trials, Inc
🇺🇸San Diego, California, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Augusta Centre for Dermatology and Skin Renewal, LLC
🇺🇸Augusta, Georgia, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Haber Dermatology & Cosmetic Surgery
🇺🇸South Euclid, Ohio, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Gwinnett Clinical Research Center, Inc.
🇺🇸Snellville, Georgia, United States
Academic Dermatology
🇺🇸Albuquerque, New Mexico, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
The Savin Center, PC
🇺🇸New Haven, Connecticut, United States
Michigan Center for Research Corp.
🇺🇸Clinton Township, Michigan, United States
Foot and Ankle Associates of Florida, Inc
🇺🇸Altamonte Springs, Florida, United States
Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
Hudson Dermatology
🇺🇸Evansville, Indiana, United States
Stratica Medical
🇨🇦Edmonton, Alberta, Canada
Dermatology Specialists
🇺🇸Louisville, Kentucky, United States
Impact Clinical Trials
🇺🇸New Hyde Park, New York, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Greenville, South Carolina, United States
Rivergate Dermatology
🇺🇸Goodlettsville, Tennessee, United States
J & S Studies, Inc.
🇺🇸College Station, Texas, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Stephen Miller, MD, PA
🇺🇸San Antonio, Texas, United States
Dermatology Resarch Center
🇺🇸Salt Lake City, Utah, United States
The Education and Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Virginia Clinical Research, Inc
🇺🇸Norfolk, Virginia, United States
Aurora Advanced Healthcare, Inc. - Clinical Research Center
🇺🇸Milwaukee, Wisconsin, United States
Mediprobe Research
🇨🇦New London, Ontario, Canada
Kaken Investigational Site - Chuo-ku
🇯🇵Sapporo, Hokkaido, Japan
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Kaken Investigational Site - Atsubetsu-ku #3
🇯🇵Sapporo, Hokkaido, Japan
Centre de Recherche Dermatologique du Québec Métropolitain
🇨🇦Québec, Quebec, Canada
Kaken Investigational Site
🇯🇵Nagasaki, Japan
Kaken Investigational Site - Atsubetsu-ku #2
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Atsubetsu-ku #1
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Kiyota-ku
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Nishi-ku
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Kita-ku
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Shiroishi-ku
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Teine-ku #1
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Teine-ku #2
🇯🇵Sapporo, Hokkaido, Japan
Kaken Investigational Site - Nakano-ku #2
🇯🇵Nakano-ku, Tokyo, Japan
Kaken Investigational Site - Setagaya-ku #2
🇯🇵Setagaya-ku, Tokyo, Japan
Kaken Investigational Site - Setagaya-ku #1
🇯🇵Setagaya-ku, Tokyo, Japan
Kaken Investigational Site - Chuo-ku #1
🇯🇵Fukuoka, Japan
Kaken Investigational Site - Higashi-ku
🇯🇵Fukuoka, Japan
Kaken Investigational Site - Okinawa #1
🇯🇵Okinawa, Japan
Kaken Investigational Site - Minami-ku #2
🇯🇵Fukuoka, Japan
Kaken Investigational Site - Shinagawa-ku #1
🇯🇵Shinagawa-ku, Tokyo, Japan
Kaken Investigational Site - Minami-ku #1
🇯🇵Fukuoka, Japan
University of California, San Francisco
🇺🇸San Francisco, California, United States
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
Kaken Investigational Site - Shinagawa-ku #2
🇯🇵Shinagawa-ku, Tokyo, Japan
Austin Dermatology Associates
🇺🇸Austin, Texas, United States
Ultranova Skincare
🇨🇦Barrie, Ontario, Canada
Kaken Investigational Site - Okinawa #2
🇯🇵Okinawa, Japan
Kaken Investigational Site - Chuo-ku #2
🇯🇵Fukuoka, Japan
Kaken Investigational Site - Nakano-ku #1
🇯🇵Nakano-ku, Tokyo, Japan
Radiant Research
🇺🇸Cinncinati, Ohio, United States